Registry evaluating flow diverters for treating brain aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study aims to assess the technical performance, safety, and clinical outcomes of intracranial aneurysms treated with flow diverter stents and endosaccular flow disruptors. It will compare various devices used in endovascular treatments, focusing on parameters such as procedure time, radiation exposure, and long-term success rates. The study seeks to fill the gap in direct comparative data regarding these evolving treatment options for aneurysms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Consecutive adult patients (18 years of age or older)
* Underwent endovascular treatment with one of the following devices:

  a. Endoluminal Flow Diverter Stents: i. Pipeline Flex (Covidien, California, USA) ii. Pipeline Flex with Shield Technology (Covidien) iii. Surpass Streamline (Stryker Neurovascular, California, USA) iv. Surpass Evolve (Stryker) v. Silk flow diverter (Balt Extrusion, Montmorency, France) vi. Flow-Redirection Intraluminal Device (FRED; MicroVention) vii. Flow-Redirection Intraluminal Device X (FRED X; MicroVention) viii. p64 Flow Modulation Device (phenox GmbH) ix. Endovascular clip system (eCLIPs) (eCLIPsTM, eVasc Neurovascular, Vancouver, BC, Canada)

  b. Intrasaccular Flow Disruptors: i. Woven EndoBridge (WEB; MicroVention) ii. Luna/Artisse System (Medtronic) iii. Medina Embolic Device (Medtronic) iv. Contour Neurovascular System (Cerus Endovascular) v. Neqstent Coil Assisted Flow Diverter (Cerus Endovascular) vi. pCONus and pCANvas (phenox GmbH) vii. Nexus Aneurysm Embolization System (EndoStream Medical) viii. CITADEL™ Embolization Device (Balt, USA)
* Complete medical records and follow-up data available

Exclusion Criteria:

* Incomplete procedural or follow-up records
* Non-flow-diverter or non-flow-disruptor treatments (e.g., coiling-only cases)
* Aneurysms treated with investigational devices not listed within Inclusion Criteria

Where it's running

• University of Miami
  Coral Gables, Florida, United States Recruiting
• Lahey Hospital and Medical Center
  Burlington, Massachusetts, United States Recruiting
• Munson Medical Center
  Traverse City, Michigan, United States Recruiting
• Allina Health
  Minneapolis, Minnesota, United States Recruiting
• Robert Wood Johnson University
  New Brunswick, New Jersey, United States Recruiting
• Montefiore Medical Center Department of Neurosurgery
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: David Altschul, MD — Montefiore Medical Center
• Study coordinator: Muhammed Amir Essibayi, MD
• Email: Muhammedamir.essibayi@einsteinmed.edu
• Phone: 347-908-1889

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Flow Diverter Stent for Intracranial Aneurysm in China

  This study tests a novel flow diverter stent to treat intracranial aneurysms in adults and follows patients through treatment and follow-up.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07821957

• Real-World Experience With the WEB Device for Intracranial Aneurysms

  This study tests how well the Woven EndoBridge device works in routine treatment of intracranial aneurysms in China across multiple centers.

  Recruiting Xuanwu Hospital, Beijing · Beijing · NCT07620626

• Choydar flow-directed mesh stent for unruptured brain aneurysms

  This trial tests the Choydar flow-directed mesh stent to see if it is safe and works for people with unruptured intracranial aneurysms in the internal carotid or vertebral arteries.

  Recruiting at 8 sites Johnson & Johnson Medical (Shanghai) Ltd. · Chenzhou and 7 other locations · NCT07228312

• Pivotal test of the Silk Vista Baby Flow Diverter for unruptured brain aneurysms

  This study tests whether the Silk Vista Baby flow diverter can safely and effectively treat a single unruptured intracranial aneurysm in adults 22–80 years old.

  Recruiting at 6 sites Balt USA · Thousand Oaks, California and 5 other locations · NCT07225075

• Pipeline Vantage post-approval safety and outcomes for intracranial aneurysm treatment

  This project will test whether the Pipeline Vantage embolization device with Shield Technology is safe and effective for adults treated for intracranial aneurysms.

  Recruiting at 10 sites Medtronic Neurovascular Clinical Affairs · Jacksonville, Florida and 9 other locations · NCT06604884

• Improving brain intervention planning using vascular mapping

  This study is testing new ways to plan brain surgeries for aneurysms and AVMs to make them safer and more effective by using advanced mapping and computer models.

  Recruiting University Hospital, Ghent · Ghent · NCT06588543

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.