An EFS to Evaluate the CGuard Prime™ Carotid Stent in Acute Ischemic Stroke

Jacobs institute

Status: Enrolling

Conditions: Acute Ischemic Stroke

Treatments: Device: CGuard Prime™ Carotid Stent System

Study type: Interventional

Funder types: Other

Identifiers

NCT06447116

CIP 004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

C Guard Arm

Experimental group

Treatment:

Device: CGuard Prime™ Carotid Stent System