Prospective, Observational, Multi-Center, Single-Arm, Consecutive Enrollment, Post-Marketing, International Registry of the Surpass™ Flow Diverter in Intracranial Arteries
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cerebral Aneurysm
- Sponsor
- Stryker Neurovascular
- Enrollment
- 150
- Locations
- 19
- Primary Endpoint
- Primary effectiveness based on the proportion of patients with 100% aneurysm occlusion
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and analyzed.
Detailed Description
This will be a prospective, observational, multi-center, single-arm, post-marketing, international registry with consecutive enrollment of a minimum of 150 patients treated with the Surpass Flow Diverter in accordance with the standard of care at up to 30 registry sites.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who are to be treated with a Surpass Flow Diverter(s) will be eligible to participate in this registry. Patients will be enrolled on a consecutive basis.
Exclusion Criteria
- •This is a standard of care registry. Patients should be excluded if standard of care at a given site is such that they are not eligible for treatment with a Surpass Flow Diverter(s).
Outcomes
Primary Outcomes
Primary effectiveness based on the proportion of patients with 100% aneurysm occlusion
Time Frame: 12 months
The proportion of patients with 100% aneurysm occlusion, based on an assessment of each patient's imaging at 12 months (± 180 days) post-procedure, and stratified across four aneurysm categories.
Secondary Outcomes
- Technical success assessed by deployment of the device with complete coverage of the aneurysm neck(Peri-procedural)