Actively Recruiting
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
Led by InspireMD · Updated on 2025-05-31
50
Participants Needed
8
Research Sites
156 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 objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures in the treatment of carotid artery stenosis in spatients at high risk for adverse events from carotid endarterectomy.
CONDITIONS
Official 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 of age.
- Willing and able to provide informed consent, follow protocol procedures, and attend follow-up visits.
- Diagnosed with carotid artery disease suitable for carotid artery stenting via the Transcarotid Artery Revascularization approach.
- Either symptomatic carotid stenosis 50% or greater with symptoms (amaurosis fugax, transient ischemic attack, or stroke within last 6 months) or asymptomatic carotid stenosis 80% or greater.
- High risk for carotid endarterectomy with at least one of the following comorbidities or anatomic conditions: age 70 or older, severe angina, congestive heart failure class III-IV, low left ventricular ejection fraction (35% or less), recent myocardial infarction (3 days to 6 weeks before procedure), multi-vessel coronary artery disease with angina, severe COPD with low lung function, permanent contralateral cranial nerve injury, restenosis after previous carotid endarterectomy, planned coronary artery bypass or valve surgery in 31-60 days after stenting, planned abdominal aortic aneurysm repair in 31-60 days after stenting, occlusion of contralateral carotid arteries, prior neck radiation or surgery, severe bilateral internal carotid artery stenosis, target lesion at or above jaw level or below clavicle, severe tandem lesions, inability to extend neck, laryngeal palsy or laryngectomy, tracheostomy, spinal immobility of the neck, hostile neck or surgically inaccessible lesion.
- Target lesion location at carotid bifurcation or proximal internal carotid artery.
- Stent landing zone diameter between 4.8 mm and 9.0 mm.
- Target lesion length 36 mm or less that can be covered by a single stent.
- At least 5 cm disease-free common carotid artery segment suitable for access, sheath insertion, and clamping.
You will not qualify if you...
- Interventional procedure or surgery on carotid, coronary, or peripheral arteries within 30 days before or after the carotid procedure.
- Open heart surgery, valvular intervention, or major operation within 30 days before or after the carotid procedure.
- Vascular anatomy preventing safe sheath insertion or stent delivery.
- Previously placed stent in the ipsilateral internal or common carotid artery.
- Total occlusion or "string sign" of the ipsilateral carotid artery.
- Presence of a filling defect or tandem lesions not coverable by a single stent.
- Stenosis of the innominate artery or proximal common carotid artery needing revascularization.
- Open neck stoma.
- History of bleeding disorders or coagulopathy.
- Hypercoagulable state.
- Alternative sources of cerebral embolus such as chronic or recent atrial fibrillation, certain cardiac abnormalities, recent heart valve implantation, or abnormal angiographic findings.
- Known allergy to nickel or titanium.
- Sensitivity to contrast media not manageable by pre-treatment.
- Sensitivity to both heparin and bivalirudin anticoagulation strategies.
- Sensitivity to antiplatelet agents and all alternative antiplatelet options.
- Known intolerance to statins.
- Life expectancy less than 3 years.
- Malignancy without specialist assessment of life expectancy.
- Evolving stroke, recent intracranial hemorrhage, or brain surgery within past 12 months.
- Stroke within 7 days that increases hemorrhage risk.
- History of major stroke with significant neurologic deficit.
- Recent transient ischemic attack, amaurosis fugax, or stroke within 48 hours.
- Female who is pregnant, lactating, or planning pregnancy.
- Dementia or neurologic condition interfering with assessments.
- Conditions making endovascular therapy impossible or unsafe.
- Prior enrollment in this trial.
- Likely non-compliance with follow-up or medication.
- Participation in another clinical trial that may interfere with this study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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