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

December 11, 2024 updated by: Yibin Fang
Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Fourth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chinese populations with intracranial aneurysms

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surpass Evolve Flow Diverter
Device: Flow diverting
Flow diverter has become the standardized treatment method for Intracranial aneurysms (IAs), which is different from angioplasty, coiling, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete aneurysm occlusion rate
Time Frame: 12(-3 ~ +6) months
12(-3 ~ +6) months
Favorable prognosis rate
Time Frame: 12(-3 ~ +6) months
mRS score 0-1
12(-3 ~ +6) months
Procedure-related complication rate
Time Frame: 12(-3 ~ +6) months
12(-3 ~ +6) months

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedural success rate
Time Frame: 12(-3 ~ +6) months
12(-3 ~ +6) months
Perioperative complication rate
Time Frame: 12(-3 ~ +6) months
12(-3 ~ +6) months
Neurological mortality rate
Time Frame: 12(-3 ~ +6) months
12(-3 ~ +6) months
Incidence of postoperative stroke/TIA
Time Frame: 12(-3 ~ +6) months
12(-3 ~ +6) months
Rates of postoperative intracranial hemorrhage and neurological deficits
Time Frame: 12(-3 ~ +6) months
12(-3 ~ +6) months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yibin Fang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Estimated)

December 13, 2024

Study Record Updates

Last Update Posted (Estimated)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYNXG202401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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