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CGuard Carotid Stent for Carotid Stenosis (C-Guardians Trial)
C-Guardians Trial Summary
This trial is designed to study the safety and effectiveness of a new stent for people with carotid artery stenosis.
C-Guardians Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowC-Guardians Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.C-Guardians Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: CGuard group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
How many participants may take part in this experiment?
"This scientific endeavour necessitates the participation of 315 eligible patients, who can register from locations like University of Florida in Jacksonville and Mercy Hospital in Saint Louis."
Are there multiple Canadian sites conducting this clinical investigation?
"This scientific trial is presently available in 15 different cities, from Jacksonville to Buffalo. It’s suggested that participants pick the closest location so they can minimize their commuting responsibilities."
Does the research study include participants of all ages, including those over twenty?
"Eligible applicants for this medical trial must lie in the range of 19 to 80 years old. Furthermore, there exist 21 trials designed specifically for those under 18 and 222 studies designated towards individuals aged 65+."
Are there any recruitment opportunities currently available with this investigation?
"Per clinicaltrials.gov, this medical experiment is currently accepting participants. This research was first introduced on July 1st 2021 and the last update was issued on June 16th 2022."
Who has the qualifications to take part in this clinical exploration?
"This clinical trial is taking in 315 patients aged between 19 and 80, all of which suffer from carotid artery stenosis. Participants must be willing to take dual antiplatelet therapy for a minimum of 30 days and have life expectancy exceeding 24 months from the index procedure date. Furthermore, female participants cannot become pregnant during the course of the study or breastfeed their infants. Symptomatic subjects are those who experienced amaurosis fugax, TIA (transient ischemic attack), or stroke within 6 months preceding enrollment while asymptomatic ones need an arterial obstruction level that exceeds 80%. Finally, elderly individuals over 70"
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