CLARYS
(2022)Objective
To assess whether the Woven EndoBridge (WEB) intrasaccular flow disruptor provides effective protection against rebleeding when used to treat ruptured bifurcation aneurysms in the acute setting.
Study Summary
• Technical success rate was 93.3% (56/60); 4 failures were rescued with coils
• WEB-related morbidity and mortality was 0% at both 1 month and 1 year; overall 1-month mortality 1.7%, 1-year mortality 3.8%
• Procedure/device-related intraoperative complication rate was 3.3%, both thromboembolic events
• Mean procedure time was 75.3 min and mean fluoroscopy time was 27.0 min; 88.3% of cases used WEB alone without adjunctive devices
Intervention
Woven EndoBridge (WEB) intrasaccular flow disruption device (WEB SL or WEB SLS) for endovascular treatment of acutely ruptured bifurcation aneurysms
Inclusion Criteria
Ruptured saccular bifurcation aneurysms (Hunt and Hess grade I-III) at basilar apex, MCA bifurcation, ICA terminus, AComA, ACA, or PComA; maximum width diameter <=10 mm; CT/MRI/LP evidence of SAH within 30 days
Study Design
Arms: Single arm: all patients treated with WEB device for ruptured bifurcation aneurysms
Patients per Arm: 60 patients (single arm); 56 with successful WEB implantation
Outcome
• Rebleeding rate at 1 year = 0%
• WEB-related morbidity and mortality at 1 month and 1 year = 0%
• Overall 1-month mortality = 1.7% (1/60); 1-year mortality = 3.8% (2/52)
• Overall 1-month morbidity (mRS >2) = 15% (9/60); 1-year morbidity = 9.6% (5/52)
• Procedure/device-related complication rate = 3.3% (2/60)
Bottom Line
Treatment of ruptured bifurcation aneurysms with the WEB device resulted in 0% rebleeding at 1 month and 1 year, with low device-related complications.
Major Points
- 0% rebleeding at 1 month and 1 year post-treatment with WEB.
- 93.3% technical success rate for WEB implantation.
- WEB-related morbidity and mortality at 1 month and 1 year were 0%.
- Overall 1-month and 1-year mortality: 1.7% and 3.8%, respectively.
- Periprocedural complications occurred in 18 patients (30%), mostly thromboembolic and without lasting sequelae.
Study Design
- Study Type
- Prospective, multicenter, single-arm study
- Randomization
- No
- Sample Size
- 60
- Follow-up
- 12 months
- Centers
- 13
- Countries
- France, Germany
Primary Outcome
Definition: Rebleeding from target aneurysm within 30 days
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 0% | - |
Limitations & Criticisms
- Single-arm study without control group
- Small sample size (n=60)
- Not randomized
- Focused only on patients treated with WEB (not all ruptured aneurysms)
Citation
Spelle L, et al. J NeuroIntervent Surg 2022;14:807–814.