Trial Details
EndoVascular Treatment Of Wide-Neck Aneurysms, an EvaLuation of Safety and EffectiVeness of Stryker Surpass Evolve™ Flow Diverter System
NCT04195568
ACTIVE_NOT_RECRUITING
DESCRIPTION
The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches
CONDITIONS
Aneurysm, Intracranial
ELIGIBILITY CRITERIA
- Inclusion Criteria
- :
1. Age is ≥ 18 and ≤ 80 years
2. Has a single unruptured target intracranial aneurysm (IA) with the following characteristics:
1. Is located on the internal carotid artery (ICA) or its branches.
2. Has a neck ≥ 4 mm, dome to neck ratio ≤ 2.0, or no discernible neck
3. Aneurysm size is ≤ 12 mm (saccular or fusiform configuration)
3. Has a parent vessel diameter ≥ 1.75 mm and ≤ 5.0 mm at both the proximal and distal segments where the implant will be placed
4. Has multiple increased risk factors for intracranial (IA) aneurysm rupture, including but not limited to, aneurysm morphology, smoking, hypertension, diabetes, age, prior and/or family history of rupture, and/or history of subarachnoid hemorrhage that may result in a benefit risk profile of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated.
