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NCT04900844 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting
A NA study of Carotid Artery Stenosis, sponsored by InspireMD.
- Active
- Registry status
- NA
- Development phase
- 317
- Enrollment target
- 18
- Study locations
NCT04900844: Active NA study of Carotid Artery Stenosis, sponsored by InspireMD.
NCT04900844 is a NA study of Carotid Artery Stenosis that is active but no longer recruiting, run by InspireMD. The registered enrollment target is 317 participants, above the 267-participant average among 4 other Carotid Artery Stenosis trials with a reported enrollment target (19% higher). The trial reports 18 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04900844, a NA study of Carotid Artery Stenosis, is active but no longer recruiting, sponsored by InspireMD.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 317 participants
- Enrollment target
- 18
- Study locations
Study Summary
The objective of this pivotal study is to evaluate the safety and efficacy of the CGuard™ Carotid Stent System in the treatment of carotid artery stenosis in symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS) to a performance goal developed from published CAS literature.
Primary Outcome
The primary endpoint is the composite of the following: * Incidence of the following Major Adverse Events: Death (allcause mortality), all Stroke, and Myocardial Infarction (DSMI) through 30-days post-index procedure, based on Clinical Events Committee (CEC) adjudication OR * Ipsilateral stroke from 31-365 day follow-up, based on Clinical Events Committee (CEC) adjudication.
Conditions Studied
Interventions
- DEVICE CGuard Carotid Stent implantation
Study Locations (18)
New York
- University of Buffalo - Buffalo
- Columbia University Irving Medical Center - New York
- Stony Brook University Hospital - Stony Brook
Tennessee
- Ballad CVA Heart Institute - Kingsport
- Turkey Creek Medical Center - Knoxville
Other
- Leszek Leic Upper-Silesian Medical Centre of the Silesian Medical University - Katowice
- John Paul II Hospital - Krakow
Florida
- University of Florida - Jacksonville
Louisiana
- Oschner Health - New Orleans
Michigan
- Ascension, St. John Hospital - Detroit
Missouri
- Mercy Hospital - St Louis
North Carolina
- Novant Health - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2021-07-01 |
| Est. Completion | 2025-10-01 |
| Phase | NA |
What the registry record for NCT04900844 still lists
NCT04900844 is an interventional study that assigns participants to a tested intervention. The registered 317 participants enrollment target is mid-sized for trials with a published cap, above the 267-participant average among 4 other Carotid Artery Stenosis trials with a reported enrollment target (19% higher).
The record links to 1 condition, with Carotid Artery Stenosis appearing as the primary indexed condition, and to 1 intervention - of which CGuard Carotid Stent implantation is the first listed.
NCT04900844 lists 18 locations in 14 states (New York, Tennessee, Other).
Frequently Asked Questions
What is clinical trial NCT04900844 about?
NCT04900844 is a clinical study titled "Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting". The objective of this pivotal study is to evaluate the safety and efficacy of the CGuard™ Carotid Stent System in the treatment of carotid artery stenosis in symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS) to a performance goal developed from published CAS literature.
What is the current status of trial NCT04900844?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 317 participants. The study started on 2021-07-01. Estimated completion is 2025-10-01.
What conditions does trial NCT04900844 study?
This clinical trial studies the following conditions: Carotid Artery Stenosis.
What interventions are being tested in trial NCT04900844?
The interventions under investigation include: CGuard Carotid Stent implantation (DEVICE).
Who is sponsoring clinical trial NCT04900844?
This trial is sponsored by InspireMD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04900844 being conducted?
This trial has 18 study locations across Florida, Louisiana, Michigan, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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