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O11/103  Primary results from the CLEAR study: safety and efficacy of the NeVa Stent Retriever for large vessel thrombectomy
  1. Serdar Geyik1,
  2. Albert Yoo2,
  3. Michael T Froehler3,
  4. Christoph J Maurer4,
  5. Tareq Kass-Hout5,
  6. Laurent Pierot6,
  7. Marc Ribo7,
  8. Audrius Sirvinskas8,
  9. Eugene Lin9,
  10. Aamir Badruddin10,
  11. Jordi Blasco11,
  12. Muhammad Taqi12,
  13. Adnan Siddiqui13,
  14. Timothy Miller14,
  15. M Shazam Hussain15,
  16. Keith Woodward16,
  17. Laurent Spelle17,
  18. Christoph Groden18,
  19. Ricardo Hanel19,
  20. Imran Chaudry20,
  21. Arturo Consoli21,
  22. Christian Ramsey22,
  23. Alberto Maud23,
  24. Osama Zaidat9,
  25. Raul Nogueira24,
  26. Diogo C Haussen25,
  27. Jens Fiehler26,
  28. Rishi Gupta27
  1. 1İ.A.Ü. VM Medical Park Florya Hastanesi, Istanbul, Turkey
  2. 2Texas Stroke Institute – Plano, Plano, USA
  3. 3Vanderbilt University, Nashville, USA
  4. 4University Hospital Augsburg, Augsburg, Germany
  5. 5University of Chicago: Hyde Park, Chicago, USA
  6. 6CHU Reims – Champagne Clinic, Reims, France
  7. 7Vall d’Hebron University Hospital, Barcelona, Spain
  8. 8Republican Vilnius University Hospital, Vilnius, Lithuania
  9. 9Mercy Health — St. Vincent Medical Center, Toledo, USA
  10. 10Community Care Network Munster, Munster, USA
  11. 11Hospital Clínic de Barcelona, Barcelona, Spain
  12. 12Vascular Neurology of Southern California: Dr. M. Asif Taqi, Thousand Oaks, USA
  13. 13University at Buffalo, Buffalo, USA
  14. 14University of Maryland Medical Center, Baltimore, USA
  15. 15Cleveland Clinic Main Campus, Cleveland, USA
  16. 16Fort Sanders, Knoxville, USA
  17. 17Bicetre Hospital, Le Kremlin-Bicêtre, France
  18. 18Universitätsmedizin Mannheim, Mannheim, Germany
  19. 19Baptist Jacksonville, Jacksonville, USA
  20. 20Mount Pleasant Avenue, Sans Souci, USA
  21. 21Hospital Foch, Suresnes, France
  22. 22Baptist Health Lexington, Lexington, USA
  23. 23Texas Tech University, Lubbock, USA
  24. 24University of Pittsburgh, Pittsburgh, USA
  25. 25Emory University, Atlanta, USA
  26. 26Eppendorf, Hamburg, Germany
  27. 27WellStar Health System, Marietta, USA


Introduction Despite the proven benefit of stent retrievers, challenges to rapid revascularization of large vessel occlusions (LVO) persist. The NeVa Stent Retriever (NeVa) is a novel stent retriever designed with openings in the basket cell structure (‘drop zones’) intended to capture organized thrombi.

Aim of Study To evaluate NeVa safety and performance for recanalizing occluded intracranial vessels.

Methods CLEAR was a prospective, multicenter, open label, single-arm, FDA-regulated IDE study. Core Lab adjudicated efficacy endpoints were recanalization rates, 90-day mRS 0–2; CEC assessed safety endpoints included: 90-day mortality, symptomatic ICH, and Serious Adverse Events related to procedure/device(PRSAE/DRSAE).

Results A total of 139 subjects were enrolled at 25 centers in the US and Europe. Mean age was 67 ± 13 years; 47% were female. Median NIHSS score was 16 (IQR: 12–20). Occlusions were located in ICA (10%), M1 (61%), M2 (27%), Basilar (1%), and PCA (1%). Mean time to first pass was 19 ± 12 minutes.

First-pass to eTICI 2b-3 occurred in 68.3% and to FPE (to eTICI 2c-3) was observed in 46.8%, eTICI 2c-3 within 3 NeVa passes occurred in 73.4% and eTICI 2b-3 in 89.9%; Final eTICI 2b-3 was achieved in 95.0%; and final eTICI 2c-3 in 74.8%. A good outcome (90-day mRS 0–2) was seen in 63%. CEC reported DRSAEs in 4.3% and PRSAE’s in 5.8% of subjects. Mortality was 9.4% with sICH in 5.8% of subjects.

Conclusion NeVa is effective and safe for revascularization of LVO strokes and demonstrates high first-pass success with strong association with functional independence.

Disclosure of Interest Nothing to disclose.

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