Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm
- Conditions
- Intracranial Aneurysms
- Registration Number
- NCT06411418
- Lead Sponsor
- State University of New York at Buffalo
- Brief Summary
The Jacobs Institute is participating in a study designed to collect prospective clinical evidence to evaluate the approved use of the Pipeline™ Flex Embolization Device with Shield Technology™ for the endovascular treatment of adults (22 years of age or older) with wide-necked intracranial aneurysms
- Detailed Description
The Pipeline™ Flex Embolization Device with Shield Technology™ for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments. The Pipeline™ Flex Embolization Device with Shield Technology™ is also indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width ≥ 4 mm or dome-to-neck ratio \< 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10
- Adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.
- Cannot provide consent or legally authorized representative not available to provide consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Occurrence of thromboembolic event(s) 60 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University at Buffalo Neurosurgery
🇺🇸Buffalo, New York, United States
University at Buffalo Neurosurgery🇺🇸Buffalo, New York, United States