Safety and Efficacy of the CGuardâ„¢ Carotid Stent System in Carotid Artery Stenting (NCT04900844) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Efficacy of the CGuardâ„¢ Carotid Stent System in Carotid Artery Stenting
United States317 participantsStarted 2021-07-01
Plain-language summary
The objective of this pivotal study is to evaluate the safety and efficacy of the CGuardâ„¢ Carotid Stent System in the treatment of carotid artery stenosis in symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS) to a performance goal developed from published CAS literature.
Who can participate
Age range19 Years – 80 Years
SexALL
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Inclusion criteria
✓. Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
✓. Subject is willing and able to take dual antiplatelet therapy for a minimum of 30 days.
✓. Life expectancy ≥ 24 months from the date of the index procedure.
✓. Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.
✓. Subject has a modified Rankin Score of ≤ 2at the time of informed consent.
✓. Subject is diagnosed with carotid artery disease treatable with carotid artery stenting and is considered high risk for carotid endarterectomy (CEA) as evidenced by:
✓. Symptomatic carotid stenosis ≥ 50%. Symptomatic is defined as amaurosis fugax, transient ischemia attack (TIA) or stroke within the last 6 months ipsilateral to the side of the stenosis.
✓. Asymptomatic carotid stenosis ≥ 80%
Exclusion criteria
✕. Planned interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure.
✕. Severe vascular anatomy that would preclude safe sheath insertion, deliverability of stent or embolic protection device.
✕. Type III or bovine aortic arch.
What they're measuring
1
Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure
Timeframe: From index procedure to 1 year follow up
✕. Presence of "String sign" of the target lesion.
✕. In-tandem lesions with \>= 50% or \>= 80% diameter stenosis for symptomatic or asymptomatic patients, respectively, which cannot be covered by a single CGuard™ stent.
✕. History of bleeding diatheses or coagulopathy or inability to accept blood transfusions.
✕. Bilateral carotid stenosis requiring treatment on both sides within 30 days prior to or following planned index procedure.