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

J Neurointerv Surg. 2024 Nov 22;16(12):1220-1227. doi: 10.1136/jnis-2023-020960.

Abstract

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.

Keywords: blood flow; device; stent; stroke; thrombectomy.

Publication types

  • Clinical Study
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Device Removal / methods
  • Endovascular Procedures / instrumentation
  • Endovascular Procedures / methods
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Stents*
  • Thrombectomy / instrumentation
  • Thrombectomy / methods
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT04514562