ROADSTER 3 Extended Follow-up Sub-Study

Long-Term Follow-up Study of ROADSTER 3 Patients

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).

Study Overview

• Status: Terminated
• Conditions: Carotid Artery Diseases
• Intervention / Treatment: Procedure: Transcarotid Artery Revascularization (TCAR)

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.

• Study Type: Observational
• Enrollment (Actual): 197

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Valley Vascular Consultants
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth
    • Tucson, Arizona, United States, 85718
      • Pima Heart & Vascular
  • California
    • La Jolla, California, United States, 92037
      • University of California, San Diego (UCSD)
    • La Mesa, California, United States, 91942
      • Sharp Grossmont
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Delray Beach, Florida, United States, 33484
      • Delray Medical Center
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • Ocala, Florida, United States, 34471
      • AdventHealth Ocala
  • Georgia
    • Cumming, Georgia, United States, 30342
      • Northside Vascular
  • Indiana
    • Evansville, Indiana, United States, 47710
      • Deaconess Research / Evansville Surgical Associates
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Acadiana Vascular Clinic / Our Lady Lourdes Heart Hospital
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Bay City, Michigan, United States, 48708
      • McLaren Heart & Vascular
    • Grand Rapids, Michigan, United States, 49503
      • Corewell Health
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • St. Luke's Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10016
      • New York University
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital
    • Rochester, New York, United States, 14623
      • University of Rochester
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Bethesda North Hospital
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center-Hospital
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Hospital
    • Harrisburg, Pennsylvania, United States, 17050
      • UPMC Pinnacle
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Medical University of South Carolina (MUSC)
  • Texas
    • Austin, Texas, United States, 78756
      • Cardiothoracic and Vascular Surgeons
    • Houston, Texas, United States, 77030
      • Memorial Hermann Southeast
    • Sugarland, Texas, United States, 77479
      • Houston Methodist Sugarland
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara
    • Roanoke, Virginia, United States, 24014
      • Carilion Roanoke Memorial
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center (CAMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who were enrolled in the ROADSTER 3 study

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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; Other Names: Carotid Artery Stenting; Carotid Revascularization

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Silk Road Medical
• Investigators: Principal Investigator: Meghan Dermody, MD, Lancaster General Hospital; Principal Investigator: Jeffrey Jim, MD, Abbott Northwestern Minneapolis Heart Institute Foundation; Principal Investigator: Marc Schermerhorn, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Long-term Follow-up; TCAR
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases
• Other Study ID Numbers: SRM-2024-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No