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Stent
CGuard Carotid Stent for Carotid Stenosis (C-Guardians Trial)
N/A
Recruiting
Led By Chris Metzger, MD
Research Sponsored by InspireMD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 or asymptomatic carotid stenosis and co-morbidity or high anatomical risk for CEA.
Subject is willing and able to take dual antiplatelet therapy for a minimum of 30 days.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1-, 2-, 3-year post-index procedure follow-up
Awards & highlights
C-Guardians Trial Summary
This trial is designed to study the safety and effectiveness of a new stent for people with carotid artery stenosis.
Who is the study for?
This trial is for adults who can consent and follow the study plan, willing to take dual antiplatelet therapy for at least 30 days, have a life expectancy of over 2 years, are not pregnant or planning pregnancy during the study, have mild disability from previous strokes, and are high risk for surgery due to carotid artery disease. Excludes those with severe neurological deficits or conditions affecting assessment, enrolled in conflicting studies, active COVID-19 infection, planned surgeries around the procedure time frame, certain vessel conditions that can't be treated with one stent.Check my eligibility
What is being tested?
The CGuard Carotid Stent System is being tested for safety and effectiveness in treating narrowing of the carotid arteries. The trial includes patients both showing symptoms and asymptomatic but at high risk if they were to undergo traditional surgery. It aims to compare results against established data from other similar procedures.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks associated with stenting include reactions to anesthesia or contrast media used during imaging tests (if pre-treatment doesn't work), bleeding complications especially if there's a history of blood disorders or inability to accept transfusions; potential issues related to known allergies including materials like nitinol and titanium.
C-Guardians Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have carotid artery disease and am at high risk for surgery, but can have stenting.
Select...
I am willing and able to take two blood-thinning medications for at least 30 days.
Select...
I am not pregnant or breastfeeding and do not plan to become pregnant during the study.
C-Guardians Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1-, 2-, 3-year post-index procedure follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1-, 2-, 3-year post-index procedure follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure
Secondary outcome measures
Composite of DSMI through 30 days or ipsilateral stroke 31 - 365 days post-index procedure for subjects that adhere to antiplatelet pharmacology.
Composite of Ipsilateral stroke, stent thrombosis, cardiovascular death or other device related clinical events
Incidence of DSMI through discharge, 30 days, 6 months, and yearly follow ups till 3 years
+6 moreC-Guardians Trial Design
1Treatment groups
Experimental Treatment
Group I: CGuard groupExperimental Treatment1 Intervention
Single experimental arm compared vs. objective performace goal
Find a Location
Who is running the clinical trial?
InspireMDLead Sponsor
6 Previous Clinical Trials
1,092 Total Patients Enrolled
Chris Metzger, MDPrincipal InvestigatorBallad Health
1 Previous Clinical Trials
295 Total Patients Enrolled
Piotr Musialek, MD DPhilPrincipal InvestigatorJohn Paul II Hospital, Krakow, Poland
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stroke caused by something other than narrowed arteries in my neck within the last year.My blood vessels cannot safely support certain medical procedures.The blood vessel being studied is completely blocked.I have carotid artery disease and am at high risk for surgery, but can have stenting.I am on dialysis or have severe kidney disease.I have a history of blood clotting disorders.The target lesion shows a "string sign."I do not have a bleeding disorder and can receive blood transfusions.I currently have COVID-19.You have had a stent placed in the specific blood vessel being studied before.You are expected to live for at least 24 months from the start of the study.I have not had a stroke, brain bleeding, or brain surgery in the last year.My aorta has a specific shape known as Type III or bovine.I have artery blockages that can't be fixed with one stent.I am willing and able to take two blood-thinning medications for at least 30 days.I am not pregnant or breastfeeding and do not plan to become pregnant during the study.I am allergic to nitinol, titanium, heparin, aspirin, or similar medications.I have a significant neurological impairment.I do not have dementia or any condition that affects my brain function.I am scheduled for a procedure on my heart or arteries within 30 days around my carotid procedure.My doctor thinks it's too risky for me to have a procedure involving blood vessels.I need treatment for narrowed arteries in my neck on both sides within 30 days around a key procedure.You are allergic to contrast media and cannot be treated for the allergy before the study.
Research Study Groups:
This trial has the following groups:- Group 1: CGuard group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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