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

N/AActive Not RecruitingNCT06447116

Jacobs institute15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Ischemic Stroke

Interventions

CGuard Prime™ Carotid Stent SystemDEVICE

CGuard Prime™ Carotid Stent System

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jacobs Institute

Buffalo, New York, United States

Outcomes

Primary Outcomes

Proportion of subjects with mRS ≤ 2 at 90 days

Time frame: 90 days

Secondary Outcomes

Rate of TICI 2b or greater; Proportion of subjects with sICH within 24 hours; and New stroke within the same territory within 7 days.

Time frame: 7 days

Data from ClinicalTrials.gov

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