Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System (EVOLVE)
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|ClinicalTrials.gov Identifier: NCT04195568|
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : September 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Aneurysm, Intracranial||Device: Surpass Evolve Flow Diverter System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||235 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||EndoVascular Treatment Of Wide-Neck Aneurysms, an EvaLuation of Safety and EffectiVeness of Stryker Surpass Evolve™ Flow Diverter System|
|Actual Study Start Date :||July 7, 2020|
|Estimated Primary Completion Date :||July 28, 2023|
|Estimated Study Completion Date :||July 31, 2025|
Experimental: Surpass Evolve Flow Diverter System
This is a prospective single arm study in which all subjects who present for flow diverter implantation, provide informed consent, and meet inclusion/exclusion criteria may receive treatment (Surpass Evolve Flow Diverter).
Device: Surpass Evolve Flow Diverter System
The Surpass Evolve Flow Diverter System is indicated for the endovascular treatment of adults (age 18 or above) with unruptured saccular wide-neck or fusiform intracranial aneurysms ≤12 mm.
- Primary Effectiveness Endpoint [ Time Frame: 12 months (± 3 months) post procedure ]The primary effectiveness endpoint of this study is a composite of 100% occlusion (Raymond 1, complete occlusion) of the target aneurysm without significant parent artery stenosis (>50% stenosis), per independent core lab assessment of digital subtraction angiography (DSA) images acquired at 12 months (± 3 months) post-procedure, and with no target aneurysm retreatment.
- Primary Safety Endpoint [ Time Frame: 12 Months (± 3 months) post procedure ]The primary safety endpoint of this study is neurologic death, or disabling stroke at 12 months as adjudicated by an independent Clinical Events Committee (CEC).
- Secondary Safety Endpoints [ Time Frame: 3 Year Follow-Up ]
The secondary safety endpoints will be evaluated throughout the study, and are as follows:
- Neurological death or major ipsilateral stroke as adjudicated by an independent Clinical Events Committee.
- Stroke in the treated vascular territory as adjudicated by a Clinical Events Committee
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195568
|Contact: Sabrina Louie, MPHemail@example.com|
|Contact: Alice Linfirstname.lastname@example.org|
|Principal Investigator:||Adam S Arthur, MD||Semmes Murphy Clinic|
|Principal Investigator:||Vitor M Pereira, MD||University Health Network, Toronto|