Trials / Active Not Recruiting
Active Not RecruitingNCT03252314
Ruptured Aneurysms Treated With Hydrogel Coils
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- Microvention-Terumo, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To determine safety and occlusion rates when second-generation hydrogel coils are used in the treatment of ruptured intracranial aneurysms.
Detailed description
RAGE is a prospective, non-randomized, multicenter, post-market study. The RAGE study is designed to determine the safety and occlusion rates of hydrogel coils in the ruptured aneurysm study population. Secondary objectives include determining clinical outcomes, packing density, occlusion stability, rates of recurrence, rebleed, retreatment, and adverse events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Second-generation hydrogel coils | Hydrogel coils 90% by length |
Timeline
- Start date
- 2017-11-27
- Primary completion
- 2025-06-01
- Completion
- 2025-12-01
- First posted
- 2017-08-17
- Last updated
- 2024-07-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03252314. Inclusion in this directory is not an endorsement.