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5-Year Check-In on artery stenting for stroke prevention

NCT ID NCT06470815

Disease control Sponsor: Silk Road Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study follows 197 people who previously had a procedure called TCAR to treat carotid artery disease. Researchers will check for strokes, deaths, and whether the artery narrows again over 2 to 5 years. The goal is to see how well the treatment holds up over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcarotid Artery Revascularization (TCAR) procedure with ENROUTE stent and neuroprotection system
What this could lead to
If successful, this study could confirm that TCAR provides lasting protection against stroke and artery re-narrowing for up to 5 years.
What could go wrong
This is a long-term follow-up of a previous study, not a new treatment test. The study was terminated early, which may limit the data collected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

197 people

The number who actually took part.

Started

Jul 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants who were enrolled in the ROADSTER 3 study

Ages

18 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

carotid artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carotid artery diseases

Contacts and locations

Locations

  • Abbott Northwestern

    Minneapolis, Minnesota, 55407, United States

  • Acadiana Vascular Clinic / Our Lady Lourdes Heart Hospital

    Lafayette, Louisiana, 70508, United States

  • AdventHealth Ocala

    Ocala, Florida, 34471, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242, United States

  • Cardiothoracic and Vascular Surgeons

    Austin, Texas, 78756, United States

  • Carilion Roanoke Memorial

    Roanoke, Virginia, 24014, United States

  • Charleston Area Medical Center (CAMC)

    Charleston, West Virginia, 25304, United States

  • Corewell Health

    Grand Rapids, Michigan, 49503, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Deaconess Research / Evansville Surgical Associates

    Evansville, Indiana, 47710, United States

  • Delray Medical Center

    Delray Beach, Florida, 33484, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • HonorHealth

    Scottsdale, Arizona, 85258, United States

  • Houston Methodist Sugarland

    Sugarland, Texas, 77479, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602, United States

  • Maine Medical Center

    Portland, Maine, 04102, United States

  • McLaren Heart & Vascular

    Bay City, Michigan, 48708, United States

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29401, United States

  • Memorial Hermann Southeast

    Houston, Texas, 77030, United States

  • Morton Plant Hospital

    Clearwater, Florida, 33756, United States

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140, United States

  • New York University

    New York, New York, 10016, United States

  • Northside Vascular

    Cumming, Georgia, 30342, United States

  • Pima Heart & Vascular

    Tucson, Arizona, 85718, United States

  • Providence Portland Medical Center-Hospital

    Portland, Oregon, 97213, United States

  • Sentara

    Norfolk, Virginia, 23507, United States

  • Sharp Grossmont

    La Mesa, California, 91942, United States

  • St. Luke's Hospital

    Chesterfield, Missouri, 63017, United States

  • St. Luke's University Hospital

    Bethlehem, Pennsylvania, 18015, United States

  • The Mount Sinai Hospital

    New York, New York, 10029, United States

  • UPMC Pinnacle

    Harrisburg, Pennsylvania, 17050, United States

  • University of California, San Diego (UCSD)

    La Jolla, California, 92037, United States

  • University of Rochester

    Rochester, New York, 14623, United States

  • Valley Vascular Consultants

    Huntsville, Alabama, 35801, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.