Trials / Recruiting
RecruitingNCT05257161
Carotid Revascularization With MicroNet Covered Stent Comparing Early Neurological Outcomes With Distal Versus Proximal EPS
Independent Randomized Clinical Trial in Carotid Revascularization With MicroNet Covered Stent (CGuard) Comparing Early Neurological Outcomes With Distal EPS Versus Proximal EPS
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 366 (estimated)
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation · Network
- Sex
- All
- Age
- 45 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The SIBERIA study demonstrated a clear advantage of CGuard stent implantation over the existing classical stent when using a distal anti-embolic device. At the same time, there is no Level 1 evidence for a difference between the proximal and distal anti-embolic device for the CGuard stent.
Conditions
- Patients With Aterosclerotic Carotid Stenosis
- Symptomatic Patients (Stenosis > 50%)
- Asymptomatic Patients (Stenosis ≥80%)
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Emboshield NAV6™ | Embolic Protection System for Carotid Artery Revascularization ( distal - filter) + stent CGuardTM™ |
| DEVICE | Mo.Ma™ | Embolic Protection System for Carotid Artery Revascularization ( proximal - occlusion) + stent CGuardTM™ |
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2026-11-01
- Completion
- 2027-01-01
- First posted
- 2022-02-25
- Last updated
- 2022-02-25
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT05257161. Inclusion in this directory is not an endorsement.