A mini-review of intrasaccular flow diverters.
Constantin Hecker, Erasmia Broussalis, Christoph J Griessenauer...
https://pubmed.ncbi.nlm.nih.gov/35580985/Actively Recruiting
Led by Montefiore Medical Center · Updated on 2026-07-10
5000
Participants Needed
13
Research Sites
N/A
Total Duration
Researchers are evaluating and comparing the technical performance, safety, and clinical outcomes of intracranial aneurysms treated with two types of devices flow diverter stents and endosaccular flow disruptors. These devices differ in their design and delivery systems, which may affect procedure time, radiation exposure, the need for additional devices, and long-term success in blocking aneurysms. Since prior trials, the field has evolved with new device approvals, but direct comparisons of outcomes between these devices remain limited. The study includes adult patients who underwent endovascular treatment using one of several approved flow diverter stents or intrasaccular flow disruptors. It is a multicenter retrospective cohort study collecting data on procedures performed with devices such as Pipeline Flex, Surpass Streamline, Silk flow diverters, Woven EndoBridge, and others. The study reviews complete medical records and follow-up data to assess outcomes and safety measures related to these treatments. Participants medical records are reviewed for technical success within 24 hours of the procedure, complications up to one month after treatment, and clinical outcomes at discharge and up to 24 months afterward. Angiographic results are assessed using grading scales at discharge and follow-up. Additional outcomes include radiation exposure, procedure duration, use of adjunct devices, aneurysm recurrence, and retreatment during 6 to 24 months post-procedure. This study aims to provide comprehensive insights into the comparative performance and safety of these devices over time.
CONDITIONS
International Registry of Intra-arterial and Endosaccular Flow Diverters (IRF)
M
Muhammed Amir Essibayi, MD
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Montefiore Medical Center
Lead Sponsor
Mayo Clinic
Collaborating Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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https://pubmed.ncbi.nlm.nih.gov/20642887/Montefiore Medical Center
Lead Sponsor
Mayo Clinic
Collaborating Sponsor