Trials / Terminated
TerminatedNCT06470815
ROADSTER 3 Extended Follow-up Sub-Study
Long-Term Follow-up Study of ROADSTER 3 Patients
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 197 (actual)
- Sponsor
- Silk Road Medical · Industry
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Not accepted
Summary
The study objective is to evaluate long-term outcomes for participants enrolled in the ROADSTER 3 study and treated with the ENROUTE Transcarotid Stent System (TSS) and ENROUTE Transcarotid Neuroprotection System (NPS).
Detailed description
This is an open label, single arm, multi-center post-market study evaluating long-term outcomes for participants at standard risk for adverse events from carotid endarterectomy who underwent carotid revascularization with the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid Neuroprotection System in the ROADSTER 3 study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Transcarotid Artery Revascularization (TCAR) | Carotid artery revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent |
Timeline
- Start date
- 2024-07-31
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2024-06-24
- Last updated
- 2026-04-17
Locations
37 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06470815. Inclusion in this directory is not an endorsement.