International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)

Recruiting now

Conditions studied: Intracranial Aneurysm

In brief

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.

Key facts

Study ID

NCT06174727

Run by

Montefiore Medical Center

People needed

5000

Starts

2023-10-01

Expected to finish

2027-07-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Toronto Western Hospital — Toronto, Ontario, Canada (enrolling)
• Allina Health — Minneapolis, Minnesota, United States (enrolling)
• Robert Wood Johnson University — New Brunswick, New Jersey, United States (enrolling)
• Montefiore Medical Center Department of Neurosurgery — The Bronx, New York, United States (enrolling)
• St. Michael's Hospital — Toronto, Ontario, Canada (enrolling)
• University of Miami — Coral Gables, Florida, United States (enrolling)
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States (enrolling)
• Munson Medical Center — Traverse City, Michigan, United States (enrolling)
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Sarasota Memorial Research Institute — Sarasota, Florida, United States
• Geisinger Health — Danville, Pennsylvania, United States
• University at Buffalo — Buffalo, New York, United States
• HCA Houston Healthcare Kingwood — Kingwood, Texas, United States

Full record on ClinicalTrials.gov

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