Trials / Active Not Recruiting
Active Not RecruitingNCT04900844
Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting
A Multicenter, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the CGuard™ Carotid Stent System When Used to Treat Symptomatic and Asymptomatic Carotid Artery Stenosis in Patients Undergoing Carotid Artery Stenting
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 317 (actual)
- Sponsor
- InspireMD · Industry
- Sex
- All
- Age
- 19 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CGuard Carotid Stent implantation | Implantation of CGuard carotid stent in the eligible patients |
Timeline
- Start date
- 2021-07-01
- Primary completion
- 2022-07-01
- Completion
- 2025-10-01
- First posted
- 2021-05-25
- Last updated
- 2025-04-04
Locations
18 sites across 2 countries: United States, Poland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04900844. Inclusion in this directory is not an endorsement.