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NCT06653387 · ClinicalTrials.gov registry record · NA
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
A NA study of Carotid Artery Diseases, sponsored by InspireMD.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 8
- Study locations
NCT06653387: Recruiting NA study of Carotid Artery Diseases, sponsored by InspireMD.
NCT06653387 is a NA study of Carotid Artery Diseases that is actively recruiting participants, run by InspireMD. The registered enrollment target is 50 participants, below the 1,666-participant average among 6 other Carotid Artery Diseases trials with a reported enrollment target (97% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06653387, a NA study of Carotid Artery Diseases, is actively recruiting participants, sponsored by InspireMD.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 8
- Study locations
Study Summary
The objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures in the treatment of carotid artery stenosis in spatients at high risk for adverse events from carotid endarterectomy.
Primary Outcome
Successful insertion of the delivery system, successful deployment of the CGuard Prime™ 80 stent, and successful retraction of the delivery system when used in conjunction with the FDA-cleared ENROUTE NPS during a TCAR procedure.
Conditions Studied
Interventions
- DEVICE CGuard Prime 80cm stent system
Study Locations (8)
New York
- Mount Sinai Hospital - New York
- University of Rochester - Rochester
California
- UC Davis Health - Sacramento
Indiana
- Indiana University School of Medicine - Indianapolis
Minnesota
- Allina - Minneapolis
Missouri
- Washington University School of Medicine - St Louis
Montana
- Benefis Health System - Great Falls
Ohio
- TriHealth - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-11-20 |
| Est. Completion | 2027-11-20 |
| Phase | NA |
What NCT06653387 shows while recruiting
NCT06653387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,666-participant average among 6 other Carotid Artery Diseases trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Carotid Artery Diseases appearing as the primary indexed condition, and to 1 intervention - of which CGuard Prime 80cm stent system is the first listed.
NCT06653387 lists 8 locations in 7 states (New York, California, Indiana).
Frequently Asked Questions
What is clinical trial NCT06653387 about?
NCT06653387 is a clinical study titled "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". The objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures in the treatment of carotid artery stenosis in spatients at high risk f...
What is the current status of trial NCT06653387?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-11-20. Estimated completion is 2027-11-20.
What conditions does trial NCT06653387 study?
This clinical trial studies the following conditions: Carotid Artery Diseases.
What interventions are being tested in trial NCT06653387?
The interventions under investigation include: CGuard Prime 80cm stent system (DEVICE).
Who is sponsoring clinical trial NCT06653387?
This trial is sponsored by InspireMD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06653387 being conducted?
This trial has 8 study locations across California, Indiana, Minnesota, Missouri, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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