Primary results from the CLEAR study of a novel stent retriever with drop zone technology
Yoo, Albert J (Texas Stroke Institute (Plano, Texas))
Geyik, Serdar (Istanbul Aydin Universitesi)
Froehler, Michael T (Vanderbilt University Medical Center (Tennessee, Estats Units d'Amèrica))
Maurer, Christoph Johannes (University Hospital Augsburg)
Kass-Hout, Tareq (University of Chicago)
Zaidat, Osama (Mercy Health Saint Vincent Medical Center (Toledo, Estats Units d'Amèrica))
Nogueira, Raul G (UPMC Stroke Institute (Pittsburgh, Estats Units d'Amèrica))
Hanel, Ricardo A (Baptist Medical Center Jacksonville (Estats Units d'Amèrica))
Pierot, Laurent (University Hospital Reims)
Spelle, Laurent (Paris-Saclay University Faculty of Medicine)
Lopes, Demetrius (Advocate Aurora Health Inc (Park Ridge, Estats Units d'Amèrica))
Hassan, Ameer E (Valley Baptist Medical Center (Harlingen, Estats Units d'Amèrica))
Širvinskas, Audrius (Vilniaus universitetas (Lithuania))
Lin, Eugene (Mercy Health Saint Vincent Medical Center (Toledo, Estat Units d'Amèrica))
Ribo, Marc (Universitat Autònoma de Barcelona)
Blasco, Jordi (Hospital Clínic i Provincial de Barcelona)
Taqi, Muhammad Asif (Vascular Neurology of Southern California)
Badruddin, Aamir (Community Healthcare System (Munster, Estats Units d'Amèrica))
Siddiqui, Adnan H (Gates Vascular Institute)
Miller, Timothy R (University of Maryland Medical Center)
Hussain, Shazam M (Cleveland Clinic)
Haussen, Diogo C (Emory University School of Medicine (Atlanta, Estats Units d'Amèrica))
Woodward, Keith (Fort Sanders Regional Medical Center (Knoxville, Estats Units d'Amèrica))
Groden, Christoph (Universitätsmedizin Mannheim)
Consoli, Arturo (Hopital Foch (Île-de-France, França))
Chaudry, M Imran (Prisma Health (Greenville, Estats Units d'Amèrica))
Ramsey, Christian (Baptist Health Lexington (Lexington, Estats Units d'Amèrica))
Maud, Alberto (Texas Tech University Health Sciences Center El Paso)
Bentley, Joshua (Southeast Health Medical Center (Dothan, Estats Units d'Amèrica))
Bajrami, Arsida (Istanbul Aydin Universitesi)
Sahnoun, Maher (CHU de Reims)
Fiehler, Jens (Eppdata GmbH (Hamburg, Alemanya))
Gupta, Rishi (Wellstar Health System (Marietta, Estats Units d'Amèrica))

Data:	2023
Resum:	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 hemorrhage (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 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). 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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Stent ; Thrombectomy ; Stroke ; Device ; Blood flow
Publicat a:	Journal of neurointerventional surgery, Vol. 16 (december 2023) , ISSN 1759-8486

DOI: 10.1136/jnis-2023-020960
PMID: 38050090

8 p, 1.2 MB

El registre apareix a les col·leccions:
Articles > Articles de recerca
Articles > Articles publicats