CLARYS
CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study
Clinical Question
Is the Woven EndoBridge (WEB) device safe and effective in preventing rebleeding in patients with ruptured bifurcation aneurysms?
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.
Design
Study Type: Prospective, multicenter, single-arm study
Randomization:
Enrollment Period: February 2016 – September 2017
Follow-up Duration: 12 months
Centers: 13
Countries: France, Germany
Sample Size: 60
Analysis: Descriptive analysis with core lab adjudication
Inclusion Criteria
- Ruptured saccular aneurysm with SAH evidence within 30 days
- Hunt and Hess grade I, II, or III
- Bifurcation location (basilar, MCA, ICA terminus, AComA, ACA, PComA)
- Maximum aneurysm width <=10 mm
- At least one attempt of treatment with a WEB device
Exclusion Criteria
- Hunt and Hess grade IV or V
- Aneurysm maximum width >10 mm
- Non-saccular aneurysm morphology
- Non-bifurcation location
- Aneurysm size/shape not appropriate for WEB device
Arms
| Field | WEB Device Group |
|---|---|
| Intervention | Woven EndoBridge (WEB) device implantation for ruptured bifurcation aneurysms |
| Duration | One-time intervention with 12-month follow-up |
Outcomes
| Outcome | Type | Control | Intervention | HR / OR / RR | P-value |
|---|---|---|---|---|---|
| Rebleeding from target aneurysm within 30 days | Primary | 0% | |||
| Periprocedural thromboembolic complications | Secondary | 16.7% | |||
| 1-month morbidity (mRS >2) | Secondary | 15.0% | |||
| 1-year morbidity (mRS >2) | Secondary | 9.6% | |||
| Thromboembolic Events | Adverse | 16.7% | |||
| Perioperative Rupture | Adverse | 3.3% | |||
| Vasospasm | Adverse | 6.7% | |||
| Hydrocephalus | Adverse | 1.7% | |||
| Non-neurologic Events | Adverse | 8.5% |
Subgroup Analysis
No formal subgroup analysis conducted; complications described by type and timing.
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)
Funding
No specific grant. Multiple authors disclosed MicroVention consulting relationships.
Based on: CLARYS (Journal of NeuroInterventional Surgery, 2022)
Authors: Spelle L, Herbreteau D, Caroff J, et al.
Citation: Spelle L, et al. J NeuroIntervent Surg 2022;14:807–814.
Content summarized and formatted by NeuroTrials.ai.