Purpose: To assess the safety and efficacy of a device for vibrational angioplasty in the

percutaneous intraluminal recanalization of long infrainguinal chronic total occlusions (CTO).

Technique: The Crosser CTO Recanalization System is a mechanical recanalization device

that uses high-frequency vibrational energy to disrupt and channel through fibrocalcific

plaque without harming the vessel wall, thus assisting in the recanalization of an occluded

artery. In 12 diabetic patients (7 men; median age 71 years, range 58–80) with critical limb

ischemia owing to long (median length 26 cm, range 21–32) infrainguinal CTOs resistant to

conventional guidewire techniques, the Crosser CTO Recanalization System was

successful in intraluminally crossing the occlusion in 9 (75%) patients in ,5 minutes

(mean 4:03 minutes). The safety endpoint (distal lumen guidewire position with no vessel

perforation or dissection) was achieved in all successful cases.

Conclusion: In our preliminary experience, the Crosser CTO Recanalization Catheter

decreased crossing time, was safe, and achieved a high rate of intraluminal recanalization

of long infrainguinal CTOs.

J Endovasc Ther. 2009;16:23–27

Key words: critical limb ischemia, chronic total occlusion, percutaneous interventions,

infrainguinal occlusion, intraluminal recanalization, vibrational energ

Gandini,R

Pipitone,V

Simonetti,G

Volpi,T

Gandini, R

Volpi, T

Pipitone, V

Simonetti, G

Cineca Institutional Research Information System

Intraluminal recanalization of long infrainguinal chronic total occlusions using the Crosser system

Purpose: To assess the safety and efficacy of a device for vibrational angioplasty in the
percutaneous intraluminal recanalization of long infrainguinal chronic total occlusions (CTO).
Technique: The Crosser CTO Recanalization System is a mechanical recanalization device
that uses high-frequency vibrational energy to disrupt and channel through fibrocalcific
plaque without harming the vessel wall, thus assisting in the recanalization of an occluded
artery. In 12 diabetic patients (7 men; median age 71 years, range 58–80) with critical limb
ischemia owing to long (median length 26 cm, range 21–32) infrainguinal CTOs resistant to
conventional guidewire techniques, the Crosser CTO Recanalization System was
successful in intraluminally crossing the occlusion in 9 (75%) patients in ,5 minutes
(mean 4:03 minutes). The safety endpoint (distal lumen guidewire position with no vessel
perforation or dissection) was achieved in all successful cases.
Conclusion: In our preliminary experience, the Crosser CTO Recanalization Catheter
decreased crossing time, was safe, and achieved a high rate of intraluminal recanalization
of long infrainguinal CTOs.
J Endovasc Ther. 2009;16:23–27
Key words: critical limb ischemia, chronic total occlusion, percutaneous interventions,
infrainguinal occlusion, intraluminal recanalization, vibrational energ

GANDINI, ROBERTO

SIMONETTI, GIOVANNI MARIA EGISTO

¤TECHNICAL NOTE ¤Intraluminal Recanalization of Long InfrainguinalChronic Total Occlusions Using the Crosser SystemRoberto Gandini, MD; Tommaso Volpi, MD; Vincenzo Pipitone, MD; andGiovanni Simonetti, MDDepartment of Diagnostic and Molecular Imaging, Interventional Radiology, NuclearMedicine and Radiation Therapy, University of Rome ‘‘Tor Vergata,’’ Rome, Italy.¤ ¤Purpose: To assess the safety and efficacy of a device for vibrational angioplasty in thepercutaneous intraluminal recanalization of long infrainguinal chronic total occlusions (CTO).Technique: The Crosser CTO Recanalization System is a mechanical recanalization devicethat uses high-frequency vibrational energy to disrupt and channel through fibrocalcificplaque without harming the vessel wall, thus assisting in the recanalization of an occludedartery. In 12 diabetic patients (7 men; median age 71 years, range 58–80) with critical limbischemia owing to long (median length 26 cm, range 21–32) infrainguinal CTOs resistant toconventional guidewire techniques, the Crosser CTO Recanalization System wassuccessful in intraluminally crossing the occlusion in 9 (75%) patients in ,5 minutes(mean 4:03 minutes). The safety endpoint (distal lumen guidewire position with no vesselperforation or dissection) was achieved in all successful cases.Conclusion: In our preliminary experience, the Crosser CTO Recanalization Catheterdecreased crossing time, was safe, and achieved a high rate of intraluminal recanalizationof long infrainguinal CTOs.J Endovasc Ther. 2009;16:23–27Key words: critical limb ischemia, chronic total occlusion, percutaneous interventions,infrainguinal occlusion, intraluminal recanalization, vibrational energy¤ ¤According to the TransAtlantic Inter-SocietyConsensus (TASC) document, the standard ofcare for critical limb ischemia (CLI) caused bylong type D infrainguinal chronic total occlu-sions (CTO) is surgical bypass grafting.1However, this approach is not possible in allcases due to significant comorbidities or tothe lack of suitable native veins for the distalbypass; in these patients, endovascular treat-ment is an important option.In long, complete infrainguinal occlusions,the technical success of conventional angio-plasty decreases as lesion length and degreeof calcification increase because of the inabil-ity to cross the occlusion with a standardguidewire.2–6 Among experienced interven-tionists, subintimal angioplasty is the mostfrequently used technique in the recanalizationof lower extremity CTOs, but the technicalchallenge of this approach is significant andhad led to the development of new devices forintraluminal treatment of these occlusions byless experienced operators. We report thetechnique for using one of these new devicesin the recanalization of infrainguinal CTOs.TECHNIQUEDevice DescriptionThe Crosser CTO Recanalization System(FlowCardia Inc, Sunnyvale, CA, USA) is aThe authors have no commercial, proprietary, or financial interest in any products or companies described in this article.Address for correspondence and reprints: Tommaso Volpi, MD, Department of Diagnostic and Molecular Imaging, InterventionalRadiology, Nuclear Medicine and Radiation Therapy, University of Rome ‘‘Tor Vergata,’’ Rome, Italy. E-mail: t.volpi@tiscali.itJ ENDOVASC THER2009;16:23–27 23 2009 by the INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS Available at www.jevt.orgmechanical recanalization device (Fig. 1) con-sisting of a generator, an attached transducer,a foot switch, and a disposable Crossercatheter. The affixed transducer has piezo-electric crystals that convert the amplifiedalternating current supplied by the generatorinto high-frequency vibrational energy, whichis then propagated at 21,000 cycles/s to thecatheter’s metal tip. The very rapid reciprocal(back and forth) stroke (depth 20 microns)disrupts and channels through fibrocalcificplaque without harming the vessel wall, thusassisting in the recanalization of an occludedartery. An irrigation line is required duringdevice activation to guarantee a continuouschilled sterile saline flush (recommendedflow rate of 18 mL/min at a back pressure of200 psi) to cool the system and provide amedium for cavitation at the catheter tip.Three different versions of this monorailhydrophilic catheter are available. The Cros-ser 14P and 14S catheters have a 1.1-mm-diameter titanium tip, are compatible with a0.014-inch guidewire, and are deliveredthrough a 5-F sheath. The Crosser 18 catheterhas a 1.5-mm titanium tip and is deliveredover a 0.018-inch guidewire via a 6-F sheath.The larger Crosser 18 catheter is suited forlarge-diameter, straight vessels with light tomoderate calcium loads, while the moreflexible designs of the Crosser 14S and 14Pmodels accommodate to more tortuous ves-sels with moderate to heavy calcification. TheCrosser 14S (Support) offers a balance be-tween vibrational drilling power, flexibility,and catheter support. The Crosser 14P wasdesigned for the most distal tibial arteries ofthe foot.Device ApplicationAfter percutaneous antegrade puncture ofthe common femoral artery is performed, a 6-F, 10-cm-long sheath is placed. A completelower limb diagnostic angiogram is obtainedto evaluate the extent of the occlusion, itsorigin, and the reconstitution site. Afteracquiring a roadmap image, a 180-cm,0.014-inch guidewire (PT Graphix super-sup-port; Boston Scientific, Natick, MA, USA) isadvanced to the occlusion site. The Crossercatheter is then advanced over the wire untilits tip is against the face of the occlusion. Theguidewire is withdrawn a few centimeterswithin the catheter. Cold saline irrigation isinitiated and the Crosser system activated.Using gentle forward pressure on the cathe-ter, the tip is slowly advanced through theocclusion. After an initial segment of strongresistance, the catheter navigates throughsections that present variable amounts ofresistance to catheter advancement. Oncethe catheter is close to the reconstitution site,diluted contrast is injected from the femoralsheath to evaluate the remaining length of thelesion. When the occlusion appears to becrossed, a further contrast injection is per-formed through the infusion lumen of thecatheter, which confirms the true lumenposition. The guidewire is then advanced intothe patent true lumen and the Crossercatheter is removed. Once an occlusion iscrossed, a prolonged (3 minutes or longer)balloon dilation is performed with 3.5-mmAmphirion Deep balloons (Invatec., Ronca-delle, Italy); stents are placed in selectedcases.The Crosser CTO Recanalization Catheterwas preliminarily evaluated in 12 patients (7men; median age 71 years, range 58–80) withCLI owing to long infrainguinal CTOs afterfailed attempts with conventional guidewiretechniques. All patients presented with TASCtype D lesions (median length 26 cm, rangeFigure 1 ¤ The Crosser device and operatingequipment.24 CROSSER SYSTEM FOR CTOGandini et al.J ENDOVASC THER2009;16:23–2721–32) involving only the superficial femoralartery (SFA) in 5 cases (Fig. 2) and the SFAwith reconstitution of the distal third of thepopliteal artery in 3 cases. In 4 cases, theocclusions involved the SFA and the poplitealartery, with reconstitution of the tibiopero-neal trunk (Fig. 3) in 2 cases and the peronealartery in 2. All the patients had diabetes andRutherford category 4 (n52), 5 (n57) or 6(n53) ischemia. All patients gave writteninformed consent, and the study was con-ducted in concordance with the local ethicscommittee.Technical success, defined as completeintraluminal crossing of the occlusion withplacement of the guidewire into the true distallumen, was achieved in 9 (75%) of 12 patients.The mean activation time for complete lesioncrossing was 4:03 minutes (range 3:24–4:54).In 2 cases, the device could not advancethrough heavy calcification at the origin of theocclusion after 5 minutes of catheter activa-tion. The other case was unsuccessful due tothe creation of a false lumen during theplacement of the guide sheath. These 3patients were treated with subintimal recan-alization. The Crosser catheter caused noperforation or dissection in the recanalizedvessels.DISCUSSIONAlthough the standard of care for longperipheral occlusions (TASC type D) is con-ventional surgical bypass,1 this approach ismarred by a significant rate of early morbidity(within the first 12 months) related to woundinfections and cardiovascular complications.Moreover, patients affected by life-threaten-ing CLI, often diabetics, are typically notcandidates for conventional surgical proce-dures; not only do they have extensivearterial wall damage that could jeopardizethe distal anastomosis, but they lack veinssuitable for surgical grafting, and in general,are in poor clinical condition. Additionally,the cost of managing the surgical patient ishigh due to the expense of the procedureitself, the hospital stay, follow-up sessions,and the health and social service resourcesoutside the hospitals.7 Because of theseshort/midterm limitations of surgery and thefrequent comorbidities of this patient popu-lation, an endovascular approach should bestrongly suggested.Unfortunately, in cases of long CTOs,conventional intraluminal crossing of thelesion is often impossible, forcing the opera-tor to switch to a technical variation, such assubintimal angioplasty (SA). The success ofthe SA technique, however, is influenced notonly by the length of the occlusion, but alsoFigure 2¤ (A) Intraprocedural diagnostic angio-gram depicts total occlusion of the SFA beyond aproximal stump, (B) with reconstitution at thedistal third of the vessel, and (C) visualization ofthe 3 runoff vessels. (D–F) Postprocedure angio-gram after stent placement demonstrating com-plete endoluminal recanalization of the SFA andpatency of the 3 runoff vessels.J ENDOVASC THER2009;16:23–27CROSSER SYSTEM FOR CTO 25Gandini et al.Figure 3¤ (A) An intraprocedural diagnostic angiogram evidenced a total occlusion at thedistal third of the SFA and of the popliteal artery with reconstitution at the origin of thebifurcation between the posterior tibial artery and the peroneal artery, which fed a patentpedal artery through malleolar branches. (B) The lesion was completely crossed with theCrosser CTO Recanalization System using a PT Grafix super-support guidewire. (C) Multipleprolonged dilations ($3 minutes) were performed with 3.5-mm Amphirion Deep balloons. (D)The completion angiogram showed complete lumen reconstitution of the femoropoplitealsegment despite a small dissection at the distal third of the SFA caused by balloon dilation,promptly treated with stent deployment.26 CROSSER SYSTEM FOR CTOGandini et al.J ENDOVASC THER2009;16:23–27by the presence of normal vessel above andbelow the occlusion and on a re-entry into thetrue lumen. Solving the latter problem oftenrequires the use of expensive lumen re-entrydevices. Furthermore, during the attempt atre-entry, a viable collateral vessel or the maintrunk to the best runoff vessel may beinadvertently occluded. In sum, the successof SA relies heavily on the operator’s ad-vanced skills and expertise; even the mostexperienced peripheral interventionist usuallyachieves a technical success rate of only,80%, which prompts many operators togive up the treatment of CTOs in their clinicalpractice.8Technological improvements have led to anexpanded arsenal of devices (e.g., new guide-wires, radiofrequency systems, and the exci-mer laser catheter) that facilitate crossinglong infrainguinal CTOs in an intraluminalfashion. Among these devices, we selectedthe Crosser system mainly due to the fact thatvibrational energy not only dissolves calcifiedlesions, but it also does not harm the vesselwall, thus avoiding the arterial perforationsassociated with lasers and radiofrequencysystems.9,10 On the other hand, excessivelycalcified lesions may lead to technical failure.The Crosser CTO Recanalization Systemallowed secure intraluminal recanalization in75% of the cases with no complications in achallenging cohort of diabetic CLI patientswith lengthy CTOs resistant to conventionalguidewires. This success rate is comparableto subintimal angioplasty,8 but it is importantto point out that the Crosser catheterachieved distal true lumen access in ,5 min-utes of catheter activation, which is shorterthan previous experiences with vibratingguidewires.11 This rapid placement of aguidewire in the distal true lumen of long,often calcified CTOs will prove valuable tointerventionists looking to shorten overallCTO procedure time, which offsets the higherupfront costs associated with using a devicelike the Crosser catheter.ConclusionIn our preliminary experience, the CrosserCTO Recanalization Catheters decreased CTOrecanalization time, were safe, and achieved ahigh rate of intraluminal recanalization. Fur-ther investigation in a broader population anddata from other centers are required tovalidate our results and demonstrate that thisdevice may help less skilled physiciansachieve recanalization in this technically chal-lenging pathology.REFERENCES1. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-Society Consensus for the Management ofPeripheral Arterial Disease (TASC II). J VascSurg. 2007;45 Suppl S:S5–67.2. Alber M, Romiti M, Brochado-Neto FC, et al.Meta-analysis of alternate autogenous veinbypass grafts to infrapopliteal arteries. J VascSurg. 2005;42:449–455.3. Ishii Y, Gossage JA, Dourado R, et al. Minimuminternal diameter of the greater saphenousvein is an important determinant of successfulfemorodistal bypass grafting that is indepen-dent of the quality of the runoff. Vascular.2004;12:225–232.4. Bates MC, AbuRahma AF. An update onendovascular therapy of the lower extremities.J Endovasc Ther. 2004;11(Suppl II):II-107–II-127.5. Loftus IM, Hayes PD, Bell PR. Subintimalangioplasty in lower limb ischaemia. J Cardi-ovasc Surg. 2004;45:217–229.6. Treiman GS. Subintimal angioplasty for infra-inguinal occlusive disease. Surg Clin N Am.2004;84:1365–1380.7. Fowkes F, Leng GC. Bypass surgery for chroniclower limb ischaemia. Cochrane Database SystRev. 2008;(2):CD002000.8. Adam DJ, Beard JD, Cleveland T, et al. Bypassversus angioplasty in severe ischaemia of theleg (BASIL): multicentre, randomised con-trolled trial. Lancet. 2005;366:1925–1934.9. Scheinert D, Laird JR, Schröder M, et al.Excimer laser-assisted recanalization of long,chronic superficial femoral artery occlusions.J Endovasc Ther. 2001;8:156–166.10. Kirvaitis RJ, Parr L, Kelly LM, et al. Recanaliza-tion of chronic total peripheral arterial occlu-sions using optical coherent reflectometry withguided radiofrequency energy: a single centerexperience. Catheter Cardiovasc Intervent.2007;69:532–540.11. Tsetis DK, Michalis LK, Rees MR, et al. Vibra-tional angioplasty in the treatment of chronicinfrapopliteal arterial occlusions: preliminaryexperience. J Endovasc Ther. 2002;9:889–895.J ENDOVASC THER2009;16:23–27CROSSER SYSTEM FOR CTO 27Gandini et al.

English

Archivio della Ricerca - Università di Roma Tor vergata

¤TECHNICAL NOTE ¤
Intraluminal Recanalization of Long Infrainguinal
Chronic Total Occlusions Using the Crosser System
Roberto Gandini, MD; Tommaso Volpi, MD; Vincenzo Pipitone, MD; and
Giovanni Simonetti, MD
Department of Diagnostic and Molecular Imaging, Interventional Radiology, Nuclear
Medicine and Radiation Therapy, University of Rome ‘‘Tor Vergata,’’ Rome, Italy.
¤ ¤
Purpose: To assess the safety and efficacy of a device for vibrational angioplasty in the
percutaneous intraluminal recanalization of long infrainguinal chronic total occlusions (CTO).
Technique: The Crosser CTO Recanalization System is a mechanical recanalization device
that uses high-frequency vibrational energy to disrupt and channel through fibrocalcific
plaque without harming the vessel wall, thus assisting in the recanalization of an occluded
artery. In 12 diabetic patients (7 men; median age 71 years, range 58–80) with critical limb
ischemia owing to long (median length 26 cm, range 21–32) infrainguinal CTOs resistant to
conventional guidewire techniques, the Crosser CTO Recanalization System was
successful in intraluminally crossing the occlusion in 9 (75%) patients in ,5 minutes
(mean 4:03 minutes). The safety endpoint (distal lumen guidewire position with no vessel
perforation or dissection) was achieved in all successful cases.
Conclusion: In our preliminary experience, the Crosser CTO Recanalization Catheter
decreased crossing time, was safe, and achieved a high rate of intraluminal recanalization
of long infrainguinal CTOs.
J Endovasc Ther. 2009;16:23–27
Key words: critical limb ischemia, chronic total occlusion, percutaneous interventions,
infrainguinal occlusion, intraluminal recanalization, vibrational energy
¤ ¤
According to the TransAtlantic Inter-Society
Consensus (TASC) document, the standard of
care for critical limb ischemia (CLI) caused by
long type D infrainguinal chronic total occlu-
sions (CTO) is surgical bypass grafting.1
However, this approach is not possible in all
cases due to significant comorbidities or to
the lack of suitable native veins for the distal
bypass; in these patients, endovascular treat-
ment is an important option.
In long, complete infrainguinal occlusions,
the technical success of conventional angio-
plasty decreases as lesion length and degree
of calcification increase because of the inabil-
ity to cross the occlusion with a standard
guidewire.2–6 Among experienced interven-
tionists, subintimal angioplasty is the most
frequently used technique in the recanalization
of lower extremity CTOs, but the technical
challenge of this approach is significant and
had led to the development of new devices for
intraluminal treatment of these occlusions by
less experienced operators. We report the
technique for using one of these new devices
in the recanalization of infrainguinal CTOs.
TECHNIQUE
Device Description
The Crosser CTO Recanalization System
(FlowCardia Inc, Sunnyvale, CA, USA) is a
The authors have no commercial, proprietary, or financial interest in any products or companies described in this article.
Address for correspondence and reprints: Tommaso Volpi, MD, Department of Diagnostic and Molecular Imaging, Interventional
Radiology, Nuclear Medicine and Radiation Therapy, University of Rome ‘‘Tor Vergata,’’ Rome, Italy. E-mail: t.volpi@tiscali.it
J ENDOVASC THER
2009;16:23–27 23
 2009 by the INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS Available at www.jevt.org
mechanical recanalization device (Fig. 1) con-
sisting of a generator, an attached transducer,
a foot switch, and a disposable Crosser
catheter. The affixed transducer has piezo-
electric crystals that convert the amplified
alternating current supplied by the generator
into high-frequency vibrational energy, which
is then propagated at 21,000 cycles/s to the
catheter’s metal tip. The very rapid reciprocal
(back and forth) stroke (depth 20 microns)
disrupts and channels through fibrocalcific
plaque without harming the vessel wall, thus
assisting in the recanalization of an occluded
artery. An irrigation line is required during
device activation to guarantee a continuous
chilled sterile saline flush (recommended
flow rate of 18 mL/min at a back pressure of
200 psi) to cool the system and provide a
medium for cavitation at the catheter tip.
Three different versions of this monorail
hydrophilic catheter are available. The Cros-
ser 14P and 14S catheters have a 1.1-mm-
diameter titanium tip, are compatible with a
0.014-inch guidewire, and are delivered
through a 5-F sheath. The Crosser 18 catheter
has a 1.5-mm titanium tip and is delivered
over a 0.018-inch guidewire via a 6-F sheath.
The larger Crosser 18 catheter is suited for
large-diameter, straight vessels with light to
moderate calcium loads, while the more
flexible designs of the Crosser 14S and 14P
models accommodate to more tortuous ves-
sels with moderate to heavy calcification. The
Crosser 14S (Support) offers a balance be-
tween vibrational drilling power, flexibility,
and catheter support. The Crosser 14P was
designed for the most distal tibial arteries of
the foot.
Device Application
After percutaneous antegrade puncture of
the common femoral artery is performed, a 6-
F, 10-cm-long sheath is placed. A complete
lower limb diagnostic angiogram is obtained
to evaluate the extent of the occlusion, its
origin, and the reconstitution site. After
acquiring a roadmap image, a 180-cm,
0.014-inch guidewire (PT Graphix super-sup-
port; Boston Scientific, Natick, MA, USA) is
advanced to the occlusion site. The Crosser
catheter is then advanced over the wire until
its tip is against the face of the occlusion. The
guidewire is withdrawn a few centimeters
within the catheter. Cold saline irrigation is
initiated and the Crosser system activated.
Using gentle forward pressure on the cathe-
ter, the tip is slowly advanced through the
occlusion. After an initial segment of strong
resistance, the catheter navigates through
sections that present variable amounts of
resistance to catheter advancement. Once
the catheter is close to the reconstitution site,
diluted contrast is injected from the femoral
sheath to evaluate the remaining length of the
lesion. When the occlusion appears to be
crossed, a further contrast injection is per-
formed through the infusion lumen of the
catheter, which confirms the true lumen
position. The guidewire is then advanced into
the patent true lumen and the Crosser
catheter is removed. Once an occlusion is
crossed, a prolonged (3 minutes or longer)
balloon dilation is performed with 3.5-mm
Amphirion Deep balloons (Invatec., Ronca-
delle, Italy); stents are placed in selected
cases.
The Crosser CTO Recanalization Catheter
was preliminarily evaluated in 12 patients (7
men; median age 71 years, range 58–80) with
CLI owing to long infrainguinal CTOs after
failed attempts with conventional guidewire
techniques. All patients presented with TASC
type D lesions (median length 26 cm, range
Figure 1¤ The Crosser device and operating
equipment.
24 CROSSER SYSTEM FOR CTO
Gandini et al.
J ENDOVASC THER
2009;16:23–27
21–32) involving only the superficial femoral
artery (SFA) in 5 cases (Fig. 2) and the SFA
with reconstitution of the distal third of the
popliteal artery in 3 cases. In 4 cases, the
occlusions involved the SFA and the popliteal
artery, with reconstitution of the tibiopero-
neal trunk (Fig. 3) in 2 cases and the peroneal
artery in 2. All the patients had diabetes and
Rutherford category 4 (n52), 5 (n57) or 6
(n53) ischemia. All patients gave written
informed consent, and the study was con-
ducted in concordance with the local ethics
committee.
Technical success, defined as complete
intraluminal crossing of the occlusion with
placement of the guidewire into the true distal
lumen, was achieved in 9 (75%) of 12 patients.
The mean activation time for complete lesion
crossing was 4:03 minutes (range 3:24–4:54).
In 2 cases, the device could not advance
through heavy calcification at the origin of the
occlusion after 5 minutes of catheter activa-
tion. The other case was unsuccessful due to
the creation of a false lumen during the
placement of the guide sheath. These 3
patients were treated with subintimal recan-
alization. The Crosser catheter caused no
perforation or dissection in the recanalized
vessels.
DISCUSSION
Although the standard of care for long
peripheral occlusions (TASC type D) is con-
ventional surgical bypass,1 this approach is
marred by a significant rate of early morbidity
(within the first 12 months) related to wound
infections and cardiovascular complications.
Moreover, patients affected by life-threaten-
ing CLI, often diabetics, are typically not
candidates for conventional surgical proce-
dures; not only do they have extensive
arterial wall damage that could jeopardize
the distal anastomosis, but they lack veins
suitable for surgical grafting, and in general,
are in poor clinical condition. Additionally,
the cost of managing the surgical patient is
high due to the expense of the procedure
itself, the hospital stay, follow-up sessions,
and the health and social service resources
outside the hospitals.7 Because of these
short/midterm limitations of surgery and the
frequent comorbidities of this patient popu-
lation, an endovascular approach should be
strongly suggested.
Unfortunately, in cases of long CTOs,
conventional intraluminal crossing of the
lesion is often impossible, forcing the opera-
tor to switch to a technical variation, such as
subintimal angioplasty (SA). The success of
the SA technique, however, is influenced not
only by the length of the occlusion, but also
Figure 2¤ (A) Intraprocedural diagnostic angio-
gram depicts total occlusion of the SFA beyond a
proximal stump, (B) with reconstitution at the
distal third of the vessel, and (C) visualization of
the 3 runoff vessels. (D–F) Postprocedure angio-
gram after stent placement demonstrating com-
plete endoluminal recanalization of the SFA and
patency of the 3 runoff vessels.
J ENDOVASC THER
2009;16:23–27
CROSSER SYSTEM FOR CTO 25
Gandini et al.
Figure 3¤ (A) An intraprocedural diagnostic angiogram evidenced a total occlusion at the
distal third of the SFA and of the popliteal artery with reconstitution at the origin of the
bifurcation between the posterior tibial artery and the peroneal artery, which fed a patent
pedal artery through malleolar branches. (B) The lesion was completely crossed with the
Crosser CTO Recanalization System using a PT Grafix super-support guidewire. (C) Multiple
prolonged dilations ($3 minutes) were performed with 3.5-mm Amphirion Deep balloons. (D)
The completion angiogram showed complete lumen reconstitution of the femoropopliteal
segment despite a small dissection at the distal third of the SFA caused by balloon dilation,
promptly treated with stent deployment.
26 CROSSER SYSTEM FOR CTO
Gandini et al.
J ENDOVASC THER
2009;16:23–27
by the presence of normal vessel above and
below the occlusion and on a re-entry into the
true lumen. Solving the latter problem often
requires the use of expensive lumen re-entry
devices. Furthermore, during the attempt at
re-entry, a viable collateral vessel or the main
trunk to the best runoff vessel may be
inadvertently occluded. In sum, the success
of SA relies heavily on the operator’s ad-
vanced skills and expertise; even the most
experienced peripheral interventionist usually
achieves a technical success rate of only
,80%, which prompts many operators to
give up the treatment of CTOs in their clinical
practice.8
Technological improvements have led to an
expanded arsenal of devices (e.g., new guide-
wires, radiofrequency systems, and the exci-
mer laser catheter) that facilitate crossing
long infrainguinal CTOs in an intraluminal
fashion. Among these devices, we selected
the Crosser system mainly due to the fact that
vibrational energy not only dissolves calcified
lesions, but it also does not harm the vessel
wall, thus avoiding the arterial perforations
associated with lasers and radiofrequency
systems.9,10 On the other hand, excessively
calcified lesions may lead to technical failure.
The Crosser CTO Recanalization System
allowed secure intraluminal recanalization in
75% of the cases with no complications in a
challenging cohort of diabetic CLI patients
with lengthy CTOs resistant to conventional
guidewires. This success rate is comparable
to subintimal angioplasty,8 but it is important
to point out that the Crosser catheter
achieved distal true lumen access in ,5 min-
utes of catheter activation, which is shorter
than previous experiences with vibrating
guidewires.11 This rapid placement of a
guidewire in the distal true lumen of long,
often calcified CTOs will prove valuable to
interventionists looking to shorten overall
CTO procedure time, which offsets the higher
upfront costs associated with using a device
like the Crosser catheter.
Conclusion
In our preliminary experience, the Crosser
CTO Recanalization Catheters decreased CTO
recanalization time, were safe, and achieved a
high rate of intraluminal recanalization. Fur-
ther investigation in a broader population and
data from other centers are required to
validate our results and demonstrate that this
device may help less skilled physicians
achieve recanalization in this technically chal-
lenging pathology.
REFERENCES
1. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-
Society Consensus for the Management of
Peripheral Arterial Disease (TASC II). J Vasc
Surg. 2007;45 Suppl S:S5–67.
2. Alber M, Romiti M, Brochado-Neto FC, et al.
Meta-analysis of alternate autogenous vein
bypass grafts to infrapopliteal arteries. J Vasc
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CROSSER SYSTEM FOR CTO 27
Gandini et al.


Roberto Gandini

Tommaso Volpi

Vincenzo Pipitone

Giovanni Simonetti

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Intraluminal Recanalization of Long Infrainguinal Chronic Total Occlusions Using the Crosser System

https://art.torvergata.it/retrieve/handle/2108/14193/136683/OK18.Intraluminal%20recanalization%20of%20long%20infrainguinal%20chronic%20total%20occlusions%20using%20the%20Crosser%20system2009.pdf

Intraluminal recanalization of long infrainguinal chronic total occlusions using the Crosser system

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