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 (successful WEB implantation) was 93.3% (56/60); the 4 failures had the WEB retrieved prior to detachment and 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%
• Neurological clinical impact related to the procedure and/or device occurred in 2/60 (3.3%), both periprocedural 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; at least one attempt of treatment with a WEB device
Study Design
Arms: Single arm: all 60 patients underwent at least one attempt of WEB treatment for ruptured bifurcation aneurysms; WEB was successfully implanted in 56/60 (93.3%), while 4 aneurysms were rescued with coils after WEB retrieval
Patients per Arm: 60 patients (single arm); 56 with successful WEB implantation, 4 rescued with coils
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)
• Patients with neurological clinical impact related to procedure and/or device = 3.3% (2/60), both periprocedural thromboembolic events
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 (56/60); 4 failures rescued with coils.
- 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.
- 23 periprocedural events occurred in 18 patients (30%); thromboembolic events were the most common single category (10/23, 16.7% of patients), and events resolved without sequelae in 16 patients.
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.