RecruitingCarotid Artery Diseases
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
Eligible age
18–79 yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
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About this study
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.
Sponsor: InspireMD
You may qualify if…
- ✓ Patient is ≥ 18 years and \< 80 years of age.
- ✓ Patient is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
- ✓ Patient is diagnosed with carotid artery disease treatable with a Carotid Artery Stent via a Transcarotid Artery Revascularization approach and is either symptomatic or asymptomatic, defined as:
- ✓ 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 Or
- ✓ Asymptomatic carotid stenosis ≥ 80%
- ✓ High Risk condition for CEA: at least one, as shown below:
- ✓ Comorbid conditions:
- ✓ Age ≥ 70 (maximum 80 years)
You may not qualify if…
- ✕ Patient had or will have an interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure.
- ✕ Patient had or will have open heart surgery or valvular intervention (percutaneous or surgical), or any major operation, within 30 days before or after the index carotid procedure.
- ✕ Vascular anatomy that would preclude safe sheath insertion or deliverability of stent
- ✕ Patient had a previously placed stent in the ipsilateral ICA or CCA.
- ✕ Total occlusion or presence of a "string sign" of the ipsilateral ICA or CCA.
- ✕ Presence of a filling defect of the target lesion.
- ✕ Tandem lesions, which cannot be covered by a single CGuard Prime™ stent.
- ✕ Patient has a stenosis of the innominate artery or proximal CCA requiring revascularization
Where it's recruiting
Source: ClinicalTrials.gov · NCT06653387 · last updated 2025-05-31