International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)
Purpose
This multicenter retrospective cohort study aims to evaluate and compare the technical performance, safety, and clinical outcomes of intracranial aneurysms treated with flow diverter stents and endosaccular flow disruptors.
Condition
- Intracranial Aneurysm
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Recruiting Locations
Coral Gables, Florida 33146
Burlington, Massachusetts 01805
Traverse City, Michigan 49684
Minneapolis, Minnesota 55404
New Brunswick, New Jersey 08901
The Bronx, New York 10467
More Details
- Status
- Recruiting
- Sponsor
- Montefiore Medical Center
Detailed Description
Flow diverters and endosaccular flow disruptors used for the treatment of intracranial aneurysms exhibit distinct procedural and clinical outcomes, with potential differences in device-specific parameters such as procedure time, radiation exposure, adjunct device requirements, and long-term angiographic success. Since the completion of the Pipeline Embolization Device (PED) for the Intracranial Treatment of Aneurysms trial, the field of flow diversion has undergone continuous evolution with the development and approval of several devices. While these devices share a similar mechanism for aneurysm occlusion, their design and delivery systems can vary significantly. Various studies have demonstrated a promising safety and efficacy profile; however, the available data for a direct comparison of the technical and clinical outcomes between these devices remains limited.