WOVEN Trial: Wingspan One-year Vascular Events
In the WEAVE on-label Wingspan cohort followed to 1 year, what was the cumulative stroke or death rate? (Single-arm follow-up of 129 of the 152 patients, no concurrent control. The dashed line is a historical medical-therapy rate shown for context only.)
Alexander et al. (J Neurointerv Surg 2021;13(4):307–310) · doi:10.1136/neurintsurg-2020-016208 · 129 patients
Population
Included
- Enrolled in the WEAVE on-label Wingspan cohort and available for 1-year follow-up (129 of 152 patients, 12 of 24 sites)
- Symptomatic intracranial atherosclerotic stenosis 70 to 99%
- At least 2 strokes or TIAs in the territory of the stenotic vessel despite optimal medical therapy
- Age 22 to 80 years
- Modified Rankin Score 3 or less at enrollment
- More than 8 days since most recent qualifying ischemic event
- Target vessel diameter 2.0 to 4.5 mm; lesion length 9 mm or less
FDA on-label Wingspan criteria (WEAVE cohort followed to 1 year; 129 of 152 patients, 12 of 24 sites)
- Age 22 to 80 years
- Symptomatic intracranial atherosclerotic stenosis of 70% to 99%
- At least 2 strokes in the vascular territory of the stenotic lesion while on medical therapy
- Baseline modified Rankin Scale score of 3 or less
- Stenting of the lesion 8 days or more after the most recent stroke
- Available for 1-year clinical follow-up in the WOVEN subset
Excluded
- Off-label use of the Wingspan stent system
- Acute stroke or TIA within 8 days of enrollment
- Allergy to aspirin, clopidogrel, or contrast media
- Untreated coagulopathy or platelet count below 100,000
- Pregnancy or breastfeeding
- Concurrent participation in another investigational device trial
Off-label use (not part of the on-label WEAVE cohort or the WOVEN follow-up)
- Any use of the Wingspan stent outside the on-label Instructions for Use criteria above
- Stenting earlier than 8 days after the qualifying stroke
- Stenting after a single qualifying stroke or for transient ischemic attack symptoms only
- Intracranial arterial stenosis of less than 70%
Source: Alexander MJ et al., J Neurointerv Surg 2021;13(4):307–310 (1-year follow-up of the WEAVE on-label cohort)· Retrieved 2026-07-22
Primary Outcome
Stroke or death at 1 year (includes 4 periprocedural events)
Historical Context
Observational context only
Historical rates come from different patient populations (initial-presentation ICAS, not refractory on-label failures), study designs, and eras. Direct comparison to WOVEN is exploratory. These data provide context only, not a randomized control arm.
| Trial / Registry | Year | N | Design | Event rate |
|---|---|---|---|---|
| SAMMPRIS stent arm | 2011 | 224 | Randomized vs medical therapy, off-label use; 1-year rate | 20% |
| SAMMPRIS medical arm | 2011 | 227 | Randomized aggressive medical management; 1-year rate | 12.2% |
| WOVEN TrialThis trial | 2021 | 129 | Single-arm 1-year follow-up of the WEAVE on-label cohort | 8.5% |
Event rate = periprocedural stroke or death. Rates are not directly comparable across studies due to differences in patient selection, operator experience, study era, and outcome assessment windows.
Study Arms
- Agent
- Gateway PTA balloon catheter for angioplasty followed by the Wingspan self-expanding nitinol stent (Stryker Neurovascular)
- Route
- Endovascular (intracranial angioplasty and stenting)
- Frequency
- Single index procedure in WEAVE; WOVEN adds clinical follow-up to 1 year
- Duration
- One-time procedure with follow-up to 1 year
- Co-interventions
- Dual antiplatelet therapy and intensive medical management as in WEAVE: aspirin plus clopidogrel around the procedure, continued antiplatelet therapy, statin, and blood-pressure control afterward.
Single-arm follow-up of the WEAVE on-label cohort; no randomized control and no pre-specified 1-year threshold. 129 of the 152 WEAVE on-label patients (about 85%) were followed at 12 of the 24 original sites. During follow-up there were 7 strokes (6 minor, 1 major) and no deaths beyond the periprocedural period; adding the 4 WEAVE periprocedural events gives 11 strokes or deaths of 129 (8.5%) at 1 year. Source: Alexander J Neurointerv Surg 2021;13(4):307–310.
Trial Design
Type
- Single-arm 1-year follow-up of the WEAVE on-label Wingspan cohort
- No control arm; descriptive safety follow-up
- 129 of 152 WEAVE on-label patients followed at 12 of 24 original sites
Timeline
One-year follow-up of the WEAVE cohort (enrolled 2014 to 2017)
N
129
Enrollment
129 of the 152 WEAVE on-label patients, followed at 12 of the 24 original US centers. One-year follow-up of the WEAVE post-market surveillance cohort. Single-arm, no control. Published J Neurointerv Surg 2021.
ClinicalTrials.gov
NCT02034058Bedside Pearl
WOVEN followed the WEAVE on-label Wingspan cohort to 1 year. Of 129 patients followed (of the original 152), there were 11 strokes or deaths (8.5%) at 1 year, including the 4 WEAVE periprocedural events: 7 new strokes during follow-up (6 minor, 1 major) and no deaths beyond the periprocedural period. WOVEN has no control arm and no pre-specified 1-year threshold, so it describes durability of the WEAVE safety signal but does not establish efficacy versus medical therapy. The SAMMPRIS medical-arm 12.2% 1-year rate is a historical reference from a different population, not a randomized comparison. Aggressive medical therapy remains first-line for symptomatic intracranial atherosclerotic disease; on-label Wingspan stenting stays a salvage option for highly selected refractory patients.