WEAVE Trial: Wingspan Stent System Post-Market Surveillance
In patients with symptomatic intracranial atherosclerotic stenosis who meet strict on-label criteria for Wingspan stenting, does the periprocedural 72-hour stroke or death rate fall below the FDA pre-specified safety benchmark of 4%?
Alexander et al. (Stroke 2019;50:889-894) · doi:10.1161/STROKEAHA.118.023996 · 152 patients
Population
Included
- 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 (Instructions for Use)
- 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
- Lesion measured at its most severe stenosis with reference to the normal luminal diameter of the target arterial segment by digital subtraction angiography
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 enrolled in the primary on-label analysis)
- 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., Stroke 2019;50:889–894· Retrieved 2026-06-09
Primary Outcome
Periprocedural stroke or death within 72 hours
Historical Context
Observational context only
Historical rates come from different patient populations, study designs, era, and operator experience levels. Direct comparison to WEAVE is exploratory. These data provide context only, not a randomized control arm.
| Trial / Registry | Year | N | Design | Event rate |
|---|---|---|---|---|
| HDE Approval Study | 2007 | 44 | Single-arm, initial FDA approval data | 4.5% |
| NIH Wingspan Registry | 2008 | 158 | Registry, mixed on/off-label use | 6.2% |
| US Wingspan Registry | 2007 | 129 | Registry, mixed on/off-label use | 6.2% |
| SAMMPRIS stent arm | 2011 | 224 | Randomized vs medical therapy, off-label use | 14.7% |
| WEAVE TrialThis trial | 2019 | 152 | Single-arm, on-label only, experienced operators | 2.6% |
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 procedure: balloon angioplasty of the stenotic lesion, then deployment of the Wingspan stent
- Duration
- One-time procedure
- Co-interventions
- Dual antiplatelet therapy before stenting: aspirin 325 mg daily plus clopidogrel 75 mg daily for at least 7 days, continued after stenting; statin and blood-pressure medication as indicated. Antiplatelet-resistance testing permitted, with medication changes for supratherapeutic (P2Y12 <80) or subtherapeutic (P2Y12 >237) values. General anesthesia with arterial-line blood-pressure monitoring used in 97.4% of cases; conscious sedation in 2.6%.
Single-arm post-market surveillance; no randomized control. FDA pre-specified a periprocedural (72-hour) stroke, bleed, and death benchmark below 4%. Balloon sized to about 80% of the true luminal diameter; mean balloon inflation pressure 6 atmospheres (nominal for the Gateway balloon). A single lesion was treated in 97% of cases; tandem lesions in 3%. Mean baseline stenosis 83%, mean residual stenosis after stenting 28%. Enrolled at 24 experienced neurointerventional centers; mean operator experience 37 Wingspan cases. Source: Alexander Stroke 2019 p.890–891, Tables 1–3.
Trial Design
Type
- Prospective single-arm post-market surveillance
- FDA-mandated safety study (IDE S140022)
- On-label use only at experienced neurointerventional centers
Timeline
Enrolled 2014 to 2017
N
152
Enrollment
152 consecutive patients at 24 US centers. Enrolled October 2014 to March 2017. FDA-mandated post-market surveillance under IDE S140022. Published Stroke 2019.
ClinicalTrials.gov
NCT02034058Bedside Pearl
WEAVE restored Wingspan stenting as a salvage option for highly selected patients who fail optimal medical therapy for intracranial atherosclerotic disease. The criteria are strict: 70 to 99% symptomatic stenosis, 2 or more strokes in territory despite optimal medications, mRS 3 or less, more than 8 days from last stroke, and experienced operator. The 2.6% periprocedural event rate met the FDA benchmark under these conditions. For most patients with intracranial atherosclerotic disease, optimal medical therapy (high-intensity statin plus dual antiplatelet therapy) remains first-line.
See also