Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting (NCT04900844) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting
United States, Poland317 participantsStarted 2021-07-01
Plain-language summary
The objective of this pivotal study is to evaluate the safety and efficacy of the CGuard™ 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 range
19 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. Total occlusion of the target vessel.
. 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.