Evaluation of Safety and Effectiveness of Stryker Surpass Evolveâ„¢ Flow Diverter System (NCT04195568) | Clinical Trial Compass
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Evaluation of Safety and Effectiveness of Stryker Surpass Evolveâ„¢ Flow Diverter System
United States248 participantsStarted 2020-07-07
Plain-language summary
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
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age is ≥ 18 and ≤ 80 years
✓. Has a single unruptured target intracranial aneurysm (IA) with the following characteristics:
✓. Is located on the internal carotid artery (ICA) or its branches.
✓. Has a neck ≥ 4 mm, dome to neck ratio ≤ 2.0, or no discernible neck
✓. Aneurysm size is ≤ 12 mm (saccular or fusiform configuration)
✓. 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
✓. 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.
Exclusion criteria
✕. Has an extradural target aneurysm
✕. Has a target aneurysm in the posterior circulation
✕. Perforator or branch vessel, inclusive of the posterior communicating artery, arises from the target aneurysm body or neck (branches or arteries must arise or connect from the parent vessel separate from the aneurysm or neck to not be excluded from study)
. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation
✕. Target aneurysm is unsuitable for flow diverter treatment
✕. Has vessel characteristics, such as severe tortuosity (cICA Type IV), stenosis (\>70%), or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device
✕. Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
✕. Has a medical contraindication to study or procedure related antiplatelet medications (aspirin, clopidogrel/Plavix, ticagrelor, and heparin), local or general anesthesia, or life-threatening allergy to contrast dye