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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06731946
Enrollment
150
Registered
2024-12-13
Start date
2024-11-29
Completion date
2025-12-31
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Arterial Aneurysm

Keywords

Intracranial Arterial Aneurysm, Surpass Evolve Flow Diverter

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.

Interventions

DEVICEFlow diverting

Flow diverter has become the standardized treatment method for Intracranial aneurysms (IAs), which is different from angioplasty, coiling, etc.

Sponsors

Yibin Fang
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Complete aneurysm occlusion rate12(-3 ~ +6) months
Favorable prognosis rate12(-3 ~ +6) monthsmRS score 0-1
Procedure-related complication rate12(-3 ~ +6) months

Secondary

MeasureTime frame
Incidence of postoperative stroke/TIA12(-3 ~ +6) months
Procedural success rate12(-3 ~ +6) months
Rates of postoperative intracranial hemorrhage and neurological deficits12(-3 ~ +6) months
Perioperative complication rate12(-3 ~ +6) months
Neurological mortality rate12(-3 ~ +6) months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026