Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms

Active, not recruiting

• Conditions: Intracranial Arterial Aneurysm

• Registration Number: NCT06731946
• Lead Sponsor: Yibin Fang

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 Timeline

• Study Start: 2024-11-29
• Status Verified: 2024-12
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age ≥ 18 years with a confirmed diagnosis of intracranial aneurysm.
2. Imaging studies confirming suitability for Surpass Evolve Flow Diverter treatment.
3. Aneurysms meeting flow diverter treatment indications (e.g., aneurysms larger than 4 mm).
4. At least six months of follow-up data available post-treatment.

Exclusion Criteria

1. Patients with acutely ruptured aneurysms or significant bleeding.
2. Patients with incomplete data or insufficient follow-up records.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete aneurysm occlusion rate	12(-3 ~ +6) months
Favorable prognosis rate	12(-3 ~ +6) months	mRS score 0-1
Procedure-related complication rate	12(-3 ~ +6) months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shanghai Fourth People's Hospital; 🇨🇳 Shanghai, China