Primary results from the CLEAR study of a novel stent retriever with Drop Zone technology

Albert J Yoo, Serdar Geyik, Michael T Froehler, Christoph Johannes Maurer, Tareq Kass-Hout, Osama O Zaidat, Raul G Nogueira, Ricardo A Hanel,
Laurent Pierot, Laurent Spelle, Demetrius Lopes, Ameer Hassan, Audrius Širvinskas, Eugene Lin, Marc Ribo, Jordi Blasco, Muhammad Asif Taqi,
Aamir Badruddin, Adnan H Siddiqui, Timothy R Miller, Shazam M Hussain, Diogo C Haussen, Keith Woodward, Christoph Groden, Arturo Consoli,
M Imran Chaudry, Christian Ramsey, Alberto Maud, Joshua Bentley, Arsida Bajrami, Maher Sahnoun, Jens Fiehler, Rishi Gupta

Journal of Neuro-Interventional Surgery– DEC 2023

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.

To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device.
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 haemorrhage (sICH).
  • 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 recanalization was observed

  • eTICI 2b–3 in 73.8% (79/107)
  • eTICI 2b67–3 in 69.2% (74/107)
  • eTICI 2c–3 in 48.6% (52/107)

Median number of passes was 1 (IQR 1–2)

  • Final recanalization rates:
    • eTICI 2b–3 in 99.1% (106/107);
    • eTICI 2b67–3 in 91.6% (98/107);
    • eTICI 2c–3 in 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).

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.