An EFS to Evaluate the CGuard Prime™ Carotid Stent in Acute Ischemic Stroke
Early Phase 1
Not yet recruiting
- Conditions
- Acute Ischemic Stroke
- Registration Number
- NCT06447116
- Lead Sponsor
- Jacobs institute
- Brief Summary
The Jacobs Institute is conducting a Sponsor Investigator study of patients ≥ 18 years to establish safety and preliminary effectiveness in treating extracranial stenosis with the CGuard Prime™ Carotid Stent in the setting as an acute ischemic stroke.
- Detailed Description
A prospective, single-arm, open-label, nonblinded EFS to assess the safety and preliminary effectiveness of the CGuard Prime™ Carotid Stent in adults (18 years of age or older) with extracranial stenosis in the setting as an acute ischemic stroke.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Patients ≥18-year-old; Carotid stenosis with at least ≥ 50% stenosis; National Institute of Health Stroke Scale (NIHSS) >/=6; and evidence of large vessel occlusion (LVO) in the anterior circulation (i.e., intracranial internal carotid artery, M1 and proximal M2) by computed tomography angiography (CTA).
Exclusion Criteria
- Cannot provide consent or legally authorized representative not available to provide consent. Evidence of intracranial hemorrhage on non-contrast CT or MRI; ASPECTS<6; and any contraindication to dual antiplatelet therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Proportion of subjects with mRS ≤ 2 at 90 days 90 days Proportion of subjects with mRS ≤ 2 at 90 days
- Secondary Outcome Measures
Name Time Method Rate of TICI 2b or greater; Proportion of subjects with sICH within 24 hours; and New stroke within the same territory within 7 days. 7 days Rate of TICI 2b or greater; Proportion of subjects with sICH within 24 hours; and New stroke within the same territory within 7 days.