Study Stopped
The decision to close the study is not related to any safety concerns or newly identified risks to patients.
ROADSTER 3 Extended Follow-up Sub-Study
Long-Term Follow-up Study of ROADSTER 3 Patients
1 other identifier
observational
197
1 country
37
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2024
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2024
CompletedFirst Posted
Study publicly available on registry
June 24, 2024
CompletedStudy Start
First participant enrolled
July 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 17, 2026
April 1, 2026
1.4 years
June 17, 2024
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (1)
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.
Interventions
Carotid artery revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent
Eligibility Criteria
Participants who were enrolled in the ROADSTER 3 study
You may qualify if:
- Participants who were enrolled in the ROADSTER 3 study and treated with the ENROUTE TSS and ENROUTE NPS
- Able to provide informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Valley Vascular Consultants
Huntsville, Alabama, 35801, United States
HonorHealth
Scottsdale, Arizona, 85258, United States
Pima Heart & Vascular
Tucson, Arizona, 85718, United States
University of California, San Diego (UCSD)
La Jolla, California, 92037, United States
Sharp Grossmont
La Mesa, California, 91942, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Delray Medical Center
Delray Beach, Florida, 33484, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
AdventHealth Ocala
Ocala, Florida, 34471, United States
Northside Vascular
Cumming, Georgia, 30342, United States
Deaconess Research / Evansville Surgical Associates
Evansville, Indiana, 47710, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Acadiana Vascular Clinic / Our Lady Lourdes Heart Hospital
Lafayette, Louisiana, 70508, United States
Maine Medical Center
Portland, Maine, 04102, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
McLaren Heart & Vascular
Bay City, Michigan, 48708, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
Abbott Northwestern
Minneapolis, Minnesota, 55407, United States
St. Luke's Hospital
Chesterfield, Missouri, 63017, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
New York University
New York, New York, 10016, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
University of Rochester
Rochester, New York, 14623, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
Providence Portland Medical Center-Hospital
Portland, Oregon, 97213, United States
St. Luke's University Hospital
Bethlehem, Pennsylvania, 18015, United States
UPMC Pinnacle
Harrisburg, Pennsylvania, 17050, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29401, United States
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78756, United States
Memorial Hermann Southeast
Houston, Texas, 77030, United States
Houston Methodist Sugarland
Sugarland, Texas, 77479, United States
Sentara
Norfolk, Virginia, 23507, United States
Carilion Roanoke Memorial
Roanoke, Virginia, 24014, United States
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, 25304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2024
First Posted
June 24, 2024
Study Start
July 31, 2024
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
April 17, 2026
Record last verified: 2026-04