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Active, not recruitingNCT06447116Updated Mar 5, 2026

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

An interventional study of CGuard Prime™ Carotid Stent System in Acute Ischemic Stroke, sponsored by Jacobs institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Jacobs institute · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Acute Ischemic Stroke

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03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 15 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Jacobs institute is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    C Guard Arm

    Device: CGuard Prime™ Carotid Stent System

Interventions

  • DeviceCGuard Prime™ Carotid Stent System

    CGuard Prime™ Carotid Stent System

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What researchers measure

Primary outcomes

  1. Proportion of subjects with mRS ≤ 2 at 90 days

    Proportion of subjects with mRS ≤ 2 at 90 days

    Time frame: 90 days

Secondary outcomes

  1. 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.

    Time frame: 7 days

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Study locations

1 site
  • Jacobs Institute
    Buffalo, New York 14203, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06447116
Lead sponsor
Jacobs institute
Responsible party
Adnan Siddiqui (Principal Investigator, Jacobs institute) — Principal investigator
First posted
Jun 6, 2024
Start date
Jan 1, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 5, 2026

Study contacts

CARLOS LOUIS PENA, PhD
study director · Jacobs institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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