Registry evaluating flow diverters for treating brain aneurysms
Outcomes of Intra-arterial and Endosaccular Flow Diverters for Treatment of Intracranial Aneurysms - International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)
This study is testing different devices used to treat brain aneurysms to see which ones work best and are safest for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 11 sites (Coral Gables, Florida and 10 other locations) |
| Trial ID | NCT06174727 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older who have undergone endovascular treatment with specified flow diverter devices or endosaccular flow disruptors.
Not a fit: Patients who have not received treatment for intracranial aneurysms or those under 18 years of age may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the most effective treatment options for patients with intracranial aneurysms.
How similar studies have performed: While various studies have shown promising results for flow diversion techniques, this specific comparative approach is relatively novel and aims to provide more definitive data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 this trial is running
Coral Gables, Florida and 10 other locations
- University of Miami — Coral Gables, Florida, United States (Recruiting)
- Mayo Clinic Florida — Jacksonville, Florida, United States (Completed)
- Sarasota Memorial Research Institute — Sarasota, Florida, United States (Recruiting)
- Lahey Hospital and Medical Center — Burlington, Massachusetts, United States (Recruiting)
- Munson Medical Center — Traverse City, Michigan, United States (Recruiting)
- Robert Wood Johnson University — New Brunswick, New Jersey, United States (Recruiting)
- University at Buffalo — Buffalo, New York, United States (Completed)
- Montefiore Medical Center Department of Neurosurgery — The Bronx, New York, United States (Recruiting)
- Geisinger Health — Danville, Pennsylvania, United States (Completed)
- HCA Houston Healthcare Kingwood — Kingwood, Texas, United States (Completed)
- Toronto Western Hospital — Toronto, Ontario, Canada (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.