ROADSTER 3 Extended Follow-up Sub-Study

Silk Road Medical

Status: Terminated

Conditions: Carotid Artery Diseases

Treatments: Procedure: Transcarotid Artery Revascularization (TCAR)

Study type: Observational

Funder types: Industry

Identifiers

NCT06470815

SRM-2024-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 197 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who were enrolled in the ROADSTER 3 study and treated with the ENROUTE TSS and ENROUTE NPS
• Able to provide informed consent

Exclusion criteria

• Participants who have exited the ROADSTER 3 study early (i.e., prior to completion of protocol required follow-up) will not participate in the sub-study

Trial design

197 participants in 1 patient group

Standard-risk patients who underwent carotid intervention

Description:

Symptomatic or asymptomatic patients with a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA), who underwent carotid artery revascularization.

Treatment:

Procedure: Transcarotid Artery Revascularization (TCAR)