ROADSTER 3 Extended Follow-up Sub-Study

Long-Term Follow-up Study of ROADSTER 3 Patients

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06470815

Enrollment

197

Registered

2024-06-24

Start date

2024-07-31

Completion date

2025-12-31

Last updated

2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Artery Diseases

Keywords

Long-term Follow-up, TCAR

Brief 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.

Interventions

PROCEDURETranscarotid Artery Revascularization (TCAR)

Carotid artery revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Ipsilateral Stroke	2-years, 3-years, 4-years, and 5-years following the index procedure	Ipsilateral stroke at 2-years, 3-years, 4-years, and 5-years following the index procedure
Ipsilateral Stroke Mortality	2-years, 3-years, 4-years, and 5-years following the index procedure	Ipsilateral stroke mortality at 2-years, 3-years, 4-years, and 5-years following the index procedure
In-stent Restenosis	2-years and 5-years following the index procedure	In-stent restenosis ≥70% at 2-years and 5-years

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMeghan Dermody, MD

Lancaster General Hospital

PRINCIPAL_INVESTIGATORJeffrey Jim, MD

Abbott Northwestern Minneapolis Heart Institute Foundation

PRINCIPAL_INVESTIGATORMarc Schermerhorn, MD

Beth Israel Deaconess Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026