A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach
Public ClinicalTrials.gov record NCT06653387. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System (80cm) When Used in Conjunction With the FDA-cleared ENROUTE Transcarotid Neuroprotection System (NPS) in Patients at High Risk for Adverse Events From Carotid Endarterectomy Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization (TCAR) Approach.
Study identification
- NCT ID
- NCT06653387
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- InspireMD
- Industry
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Interventions
- CGuard Prime 80cm stent system Device
Device
Eligibility (public fields only)
- Age range
- 18 Years to 79 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 19, 2024
- Primary completion
- Nov 19, 2026
- Completion
- Nov 19, 2027
- Last update posted
- May 30, 2025
2024 – 2027
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC Davis Health | Sacramento | California | 95817 | Recruiting |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | Recruiting |
| Allina | Minneapolis | Minnesota | 55407 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Benefis Health System | Great Falls | Montana | 59405 | Recruiting |
| Mount Sinai Hospital | New York | New York | 10029 | Recruiting |
| University of Rochester | Rochester | New York | 14642 | Recruiting |
| TriHealth | Cincinnati | Ohio | 45220 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06653387, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 30, 2025 · Synced May 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06653387 live on ClinicalTrials.gov.