Journal article
WEAVE Trial
Stroke, Vol.50(4), pp.889-894
01 Apr 2019
Abstract
Background and Purpose- The WEAVE trial (Wingspan Stent System Post Market Surveillance) is a postmarket surveillance trial mandated by the Food and Drug Administration to assess the periprocedural safety of the Wingspan Stent system in the treatment of symptomatic intracranial atherosclerotic disease. Methods- A total of 152 consecutive patients who met the Food and Drug Administration on-label usage criteria were enrolled at 24 hospitals and underwent angioplasty and stenting with the Wingspan stent. On-label criteria included age 22 to 80 years, symptomatic intracranial atherosclerotic stenosis of 70% to 99%, baseline modified Rankin Scale score ≤3, ≥2 strokes in the vascular territory of the stenotic lesion with at least 1 stroke while on medical therapy, and stenting of the lesion ≥8 days after the last stroke. The primary analysis assessed the periprocedural stroke, bleed, and death rate within 72 hours of the procedure with adjudication by a core study Stroke Neurologist. Results- The trial was stopped early after interim analysis of 152 consecutive patients demonstrated a lower than expected 2.6% (4/152 patients) periprocedural stroke, bleed, and death rate. This was lower than the 4% periprocedural primary event safety benchmark set for the interim analysis in the study. A total of 97.4% (148/152) patients were event-free at 72 hours, 1.3% (2/152) had nonfatal strokes, and 1.3% (2/152) of patients died. Conclusions- With experienced interventionalists, and proper patient selection following the on-label usage guidelines, the use of the Wingspan stent for intracranial atherosclerotic disease demonstrated a low periprocedural complication rate and excellent safety profile. This is the largest on-label, multicenter, prospective trial of the Wingspan stent system to date with the lowest reported complication rate. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02034058.
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Details
- Title
- WEAVE Trial
- Creators
- Michael J AlexanderAlois ZaunerJohn C ChaloupkaBlaise BaxterRichard C CallisonRishi GuptaShlee S SongWengui YuLei FengDavid BonovichGabor TothBrian KottErol VeznedarogluAndrew RingerPhilip MeyersJohn AgolaBasavaraj GhodkeAbdulnasser AlhajeriJustin FraserCurtis GivenEric Lopez de ValleQaisar ShahGary NesbitAmeer HassanThomas GrobelnyRichard FesslerHarish Shownkeen
- Publication Details
- Stroke, Vol.50(4), pp.889-894
- Publisher
- eScholarship, University of California
- Number of pages
- 889 - 894
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Neurosurgery
- Identifiers
- 991021962289704721