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NCT Number: NCT06731946

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Fourth People's Hospital

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flow diverting

Device

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

Primary outcomes

  1. Complete aneurysm occlusion rate

    Time frame: 12(-3 ~ +6) months

  2. Favorable prognosis rate

    Time frame: 12(-3 ~ +6) months

    mRS score 0-1

  3. Procedure-related complication rate

    Time frame: 12(-3 ~ +6) months

Secondary outcomes

  1. Procedural success rate

    Time frame: 12(-3 ~ +6) months

  2. Perioperative complication rate

    Time frame: 12(-3 ~ +6) months

  3. Neurological mortality rate

    Time frame: 12(-3 ~ +6) months

  4. Incidence of postoperative stroke/TIA

    Time frame: 12(-3 ~ +6) months

  5. Rates of postoperative intracranial hemorrhage and neurological deficits

    Time frame: 12(-3 ~ +6) months

Sponsors and collaborators

Lead sponsor

Yibin Fang

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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