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Endovascular treatment of acutely ruptured shallow intradural aneurysms not amendable to clipping and coiling with the pipeline vantage embolization device

Primary Objective

The purpose of the study is to assess the safety and effectiveness of the Pipeline Flex Embolization Device with Shield Technology in the treatment with acutely ruptured intracranial aneurysms.

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Description

The purpose of this study is to assess the safety (short and long term side effects) and effectiveness (how well it stops the blood flow into the aneurysm) of the study device for the treatment of adults (22 – 80 years of age) with acutely ruptured, intradural (inside the head) aneurysms that are shallow and that are not ideal for alternative treatment (clipping and coiling).

Details
Age
Adult
Eligibility
Inclusion Criteria: intradural acutely ruptured shallow aneurysms Subject has a previously untreated, wide neck, side-wall, intradural aneurysm that is deemed unfavorable for both surgical clipping and endovascular coiling, as confirmed on DSA. Subject has a ruptured intracranial aneurysm with vessel diameter suitable for treatment with the study device. Subject is ≥ 22 and ≤ 80 years of age.
Locations

University of Colorado Hospital

Principal Investigator
Photograph of David Case

David Case

Study ID

Protocol Number: 20-1254

More information available at ClinicalTrials.gov: NCT04391803

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