Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Complete aneurysm occlusion rate
Study Overview
Brief Summary
Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms
Detailed Description
This study aims to retrospectively evaluate the efficacy and safety of the Surpass Evolve Flow Diverter in treating complex intracranial aneurysms. It seeks to assess long-term outcomes and complication rates while analyzing the impact of patient characteristics and aneurysm types on treatment effectiveness. By collecting data from multiple centers, the study ensures broad representativeness, ultimately providing valuable insights for clinical management on a global scale.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years with a confirmed diagnosis of intracranial aneurysm.
- •Imaging studies confirming suitability for Surpass Evolve Flow Diverter treatment.
- •Aneurysms meeting flow diverter treatment indications (e.g., aneurysms larger than 4 mm).
- •At least six months of follow-up data available post-treatment.
Exclusion Criteria
- •Patients with acutely ruptured aneurysms or significant bleeding.
- •Patients with incomplete data or insufficient follow-up records.
Outcomes
Primary Outcomes
Complete aneurysm occlusion rate
Time Frame: 12(-3 ~ +6) months
Favorable prognosis rate
Time Frame: 12(-3 ~ +6) months
mRS score 0-1
Procedure-related complication rate
Time Frame: 12(-3 ~ +6) months
Secondary Outcomes
- Procedural success rate(12(-3 ~ +6) months)
- Perioperative complication rate(12(-3 ~ +6) months)
- Neurological mortality rate(12(-3 ~ +6) months)
- Incidence of postoperative stroke/TIA(12(-3 ~ +6) months)
- Rates of postoperative intracranial hemorrhage and neurological deficits(12(-3 ~ +6) months)
Investigators
Yibin Fang
Dr.
Shanghai Fourth People's Hospital Tongji University