Actively Recruiting
A Multicenter, Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System (80cm) With the ENROUTE Transcarotid Neuroprotection System in High-Risk Patients Undergoing Carotid Artery Stenting
Led by InspireMD · Updated on 2025-05-31
50
Participants Needed
8
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
InspireMD
Lead Sponsor
W
Washington University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates the use of the CGuard Prime Carotid Stent System combined with the ENROUTE Transcarotid Neuroprotection System during Transcarotid Artery Revascularization procedures. It focuses on patients with carotid artery stenosis who are at high risk for problems from carotid endarterectomy. The study is a prospective, multi-center, single-arm pivotal trial aiming to evaluate the acute device and technical success of this device combination. Participants will undergo the Transcarotid Artery Revascularization procedure using the CGuard Prime 80cm stent system alongside the FDA-cleared ENROUTE Neuroprotection System. The study will enroll a minimum of 50 pivotal patients, with an additional roll-in cohort possible. Patients are screened for eligibility before enrollment, and the study is not blinded. The procedure is done once, and follow-up assessments extend up to one year. During the study, participants will be monitored from enrollment through follow-up visits for up to one year. Researchers will assess acute device success and technical success, along with secondary outcomes such as procedural and treatment success, rates of death, stroke, myocardial infarction, stent thrombosis, and serious adverse events within 30 days and up to one year. The study emphasizes safety and effectiveness monitoring through regular follow-ups to evaluate these outcomes.
CONDITIONS
Brief Title
A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years or older and younger than 80 years.
- Patient is willing and able to provide informed consent and follow study procedures.
- Patient has carotid artery disease treatable with carotid artery stenting via a Transcarotid Artery Revascularization approach.
- Patient has symptomatic carotid stenosis of 50% or more or asymptomatic stenosis of 80% or more.
- Patient has at least one high-risk condition for carotid endarterectomy, such as age 70 or older, severe angina, congestive heart failure, low ejection fraction, recent heart attack, multi-vessel coronary artery disease with angina, chronic obstructive pulmonary disease, previous nerve injury, restenosis, or planned heart or aneurysm surgery.
- Patient has anatomical conditions suitable for the device, including vessel size and lesion location criteria.
You will not qualify if you...
- Patient had or will have interventional procedures or surgery on carotid, coronary, or peripheral arteries within 30 days before or after the carotid procedure.
- Patient had or will have open heart surgery, valve intervention, or major operation within 30 days before or after the carotid procedure.
- Vascular anatomy prevents safe device insertion or stent delivery.
- Patient has a previously placed stent in the treated arteries.
- Total occlusion or "string sign" in the treated arteries.
- Presence of filling defect or multiple lesions that cannot be covered by one stent.
- Patient has stenosis of innominate artery or proximal carotid artery requiring treatment.
- Open neck stoma or history of bleeding disorders or clotting problems.
- Known sources of emboli such as atrial fibrillation, heart valve issues, or certain angiographic abnormalities.
- Allergies or sensitivities to nickel, titanium, contrast media, anticoagulants, antiplatelets, or statins.
- Life expectancy less than 3 years or active malignancy without specialist assessment.
- Recent or evolving stroke, brain hemorrhage, or major stroke with significant deficit.
- Recent transient ischemic attack or amaurosis fugax within 48 hours.
- Pregnant or lactating females.
- Dementia or neurological conditions that affect assessment.
- Conditions making endovascular therapy unsafe.
- Previous enrollment in this trial or participation in conflicting clinical trials.
- Likely non-compliance with follow-up or medication.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo carotid artery stenting using the CGuard Prime 80cm stent system with the ENROUTE Transcarotid Neuroprotection System via the Transcarotid Artery Revascularization approach.
1 procedure visit (in-person)
Duration - 30 days
Participants are monitored for procedural success, technical success, and any adverse events up to 30 days after the procedure.
Follow-up visits within 30 days after procedure, exact number varies
Duration - Up to 1 year
Participants are observed for device success, technical success, and any adverse events up to 1 year after the procedure.
Periodic follow-up visits up to 1 year after procedure
Trial Site Locations
Total: 8 locations
1
UC Davis Health
Sacramento, California, United States, 95817
Actively Recruiting
2
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
Allina
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Benefis Health System
Great Falls, Montana, United States, 59405
Actively Recruiting
6
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
7
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
8
TriHealth
Cincinnati, Ohio, United States, 45220
Actively Recruiting
Research Team
I
InspireMD/NAMSA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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