ROADSTER 3 Extended Follow-up Sub-Study

NCT ID: NCT06470815

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-31

Study Completion Date

2029-07-31

Brief Summary

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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

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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

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Carotid Artery Diseases

Keywords

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Long-term Follow-up TCAR

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard-risk patients who underwent carotid intervention

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.

Transcarotid Artery Revascularization (TCAR)

Intervention Type PROCEDURE

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

Interventions

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Transcarotid Artery Revascularization (TCAR)

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

Intervention Type PROCEDURE

Other Intervention Names

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Carotid Revascularization Carotid Artery Stenting

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Silk Road Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meghan Dermody, MD

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Jeffrey Jim, MD

Role: PRINCIPAL_INVESTIGATOR

Abbott Northwestern Minneapolis Heart Institute Foundation

Marc Schermerhorn, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Valley Vascular Consultants

Huntsville, Alabama, United States

Site Status

HonorHealth

Scottsdale, Arizona, United States

Site Status

Pima Heart & Vascular

Tucson, Arizona, United States

Site Status

University of California, San Diego (UCSD)

La Jolla, California, United States

Site Status

Sharp Grossmont

La Mesa, California, United States

Site Status

Morton Plant Hospital

Clearwater, Florida, United States

Site Status

Delray Medical Center

Delray Beach, Florida, United States

Site Status

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

AdventHealth Ocala

Ocala, Florida, United States

Site Status

Northside Vascular

Cumming, Georgia, United States

Site Status

Deaconess Research / Evansville Surgical Associates

Evansville, Indiana, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Acadiana Vascular Clinic / Our Lady Lourdes Heart Hospital

Lafayette, Louisiana, United States

Site Status

Maine Medical Center

Portland, Maine, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

McLaren Heart & Vascular

Bay City, Michigan, United States

Site Status

Corewell Health

Grand Rapids, Michigan, United States

Site Status

Abbott Northwestern

Minneapolis, Minnesota, United States

Site Status

St. Luke's Hospital

Chesterfield, Missouri, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

New York University

New York, New York, United States

Site Status

The Mount Sinai Hospital

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Bethesda North Hospital

Cincinnati, Ohio, United States

Site Status

Providence Portland Medical Center-Hospital

Portland, Oregon, United States

Site Status

St. Luke's University Hospital

Bethlehem, Pennsylvania, United States

Site Status

UPMC Pinnacle

Harrisburg, Pennsylvania, United States

Site Status

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Site Status

Cardiothoracic and Vascular Surgeons

Austin, Texas, United States

Site Status

Memorial Hermann Southeast

Houston, Texas, United States

Site Status

Houston Methodist Sugarland

Sugarland, Texas, United States

Site Status

Sentara

Norfolk, Virginia, United States

Site Status

Carilion Roanoke Memorial

Roanoke, Virginia, United States

Site Status

Charleston Area Medical Center (CAMC)

Charleston, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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SRM-2024-01

Identifier Type: -

Identifier Source: org_study_id