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

Launched by MONTEFIORE MEDICAL CENTER · Dec 13, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how well different types of flow diverter stents work for treating intracranial aneurysms, which are bulges in blood vessels in the brain. Researchers want to understand both the technical aspects of the treatment—like how successfully the stents are placed—and the overall health outcomes for patients after the procedure. This study is currently recruiting participants who are at least 18 years old and have already undergone a flow diverter stent procedure using specific devices.

If you or a loved one has had this type of treatment using one of the approved devices and meets the age requirement, you may be eligible to participate. Participants will be asked to share their experiences and health outcomes following the procedure. It's important to note that this study does not include patients who were treated with devices not listed in the eligibility criteria. Overall, this trial aims to gather valuable information that could help improve future treatments for intracranial aneurysms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients (18 years of age or older)
• * Underwent endovascular treatment with one of the following devices:
• • a. 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).
• • b. Endosaccular 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