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NCT06447116 Clinical Trial

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

Acute Ischemic Stroke Clinical Trial

Official title:
An EFS to Evaluate the Safety and Preliminary Effectiveness of the CGuard Prime™ Carotid Stent Placement in the Procedure Setting of Acute Ischemic Stroke.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06447116
Other study ID # CIP 004
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date July 1, 2024
Est. completion date December 31, 2025

Study information
Verified date June 2024
Source Jacobs institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Not yet recruiting
Enrollment 15
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• CGuard Prime™ Carotid Stent System
CGuard Prime™ Carotid Stent System

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Jacobs institute

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of subjects with mRS = 2 at 90 days Proportion of subjects with mRS = 2 at 90 days 90 days
Secondary Rate of TICI 2b or greater; Proportion of subjects with sICH within 24 hours; and New stroke within the same territory within 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. 7 days
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