Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device
Part of paid clinical trials in Aliso Viejo, California.
- Sponsor
- Microvention-Terumo, Inc.
- Study ID
- NCT05453240
- Status
- Enrolling By Invitation
Conditions
- Intracranial Aneurysms
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
The proposed study is a multi-center single arm retrospective and prospective data collection, of patients treated with the LVIS device of specific sizes of 3.5mm, 4.0mm, 4.5mm, 5.5mm with up to 5 years follow-up. Information collected during the study will be standardized across centers to include pre-treatment baseline characteristics of patients including aneurysm(s) symptoms, procedural information, prespecified clinical safety events of interest, and follow-up imaging, clinical visits or telephone calls.
Key Dates
- Start date
- Nov 17, 2020
- Status verified
- Jun 2025
- Primary completion
- Oct 1, 2025
- Completion
- Jan 1, 2026
Study Design
- Enrollment
- 250 participants (estimated)
Primary Outcome Measure
Complete or Stable Raymond Roy II [ Time Frame: 5 year ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Microvention | Aliso Viejo | California | 92656 | - |
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