Primary results from the CLEAR study of a novel stent retriever with drop zone technology

Background: Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval. Objective: To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device. Methods: Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a -10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0-2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH). Results: From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12-20). In the primary analysis population (n=107), eTICI 2b-3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b-3 was observed in 73.8% (79/107), with first pass eTICI 2b67-3 in 69.2% (74/107) and eTICI 2c-3 in 48.6% (52/107). Median number of passes was 1 (IQR 1-2). Final eTICI 2b-3 rate was 99.1% (106/107); final eTICI 2b67-3 rate was 91.6% (98/107); final eTICI 2c-3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0-2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139). Conclusions: The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal. Trial registration number: NCT04514562

Multicenter Analysis of Stenting in Symptomatic Intracranial Atherosclerosis

Abstract BACKGROUND Stenting for symptomatic intracranial atherosclerotic disease is a therapeutic option in patients in whom medical therapy fails. OBJECTIVE To determine the periprocedural complication rates and mid-term restenosis rates in patients treated with balloon-expandable stents (BESs) compared with self-expanding stents (SESs). METHODS A retrospective review of consecutive patients treated with intracranial stents at 5 institutions was performed. Predictors of 30-day stroke and death as well as mid-term restenosis rates were analyzed. RESULTS A total of 670 lesions were treated in 637 patients with a mean age of 57 ± 13 years. A total of 454 lesions (68%) were treated with BESs and 216 lesions (32%) with SESs. The overall 30-day periprocedural complication rate was 6.1%, without any difference noted between the 2 groups. Patients treated within 24 hours of the index event were significantly more likely to have experienced a periprocedural complication (odds ratio [OR], 4.0; 95% confidence interval [CI]: 1.7-6.7; P > .007), whereas focal lesions were less likely to have a complication (OR, 0.31; 95% CI: 0.13-0.72; P > .001). Midterm restenosis was less likely in patients with a lower percentage of posttreatment stenosis (OR, 0.97; 95% CI: 0.95-0.99; P > .006), which was more common in BES-treated patients and focal concentric lesions (OR, 0.33; 95% CI: 0.23-0.55; P > .0001). CONCLUSION BESs have periprocedural complication rates similar to those of SESs. Less posttreatment stenosis was associated with lower rates of mid-term restenosis. Future randomized trials comparing BESs and SESs may help to identify the stent type that is safest and most durable