Status:
RECRUITING
International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Mayo Clinic
Simpson Memorial Research Institute
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18+ years
Brief Summary
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 endosa...
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 parame...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT06174727
Start Date
October 1 2023
End Date
June 1 2026
Last Update
January 7 2026
Active Locations (11)
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1
University of Miami
Coral Gables, Florida, United States, 33146
2
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
3
Sarasota Memorial Research Institute
Sarasota, Florida, United States, 34239
4
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805