ROADSTER 3 Extended Follow-up Sub-Study
Launched by SILK ROAD MEDICAL · Jun 17, 2024
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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
About Silk Road Medical
Silk Road Medical is a pioneering medical device company focused on transforming the treatment of carotid artery disease through innovative technologies and minimally invasive procedures. Committed to enhancing patient outcomes, the company specializes in the development of the ENROUTE Transcarotid Neuroprotection System and other advanced solutions designed to reduce stroke risk during carotid interventions. With a strong emphasis on clinical research and rigorous testing, Silk Road Medical aims to set new standards in vascular health, reinforcing its dedication to improving the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Portland, Maine, United States
Hackensack, New Jersey, United States
Lebanon, New Hampshire, United States
Clearwater, Florida, United States
Elk Grove Village, Illinois, United States
Cincinnati, Ohio, United States
Pittsburgh, Pennsylvania, United States
Indianapolis, Indiana, United States
Washington, District Of Columbia, United States
Miami Beach, Florida, United States
Rochester, New York, United States
Chesterfield, Missouri, United States
New York, New York, United States
Lancaster, Pennsylvania, United States
Austin, Texas, United States
Minneapolis, Minnesota, United States
Charleston, West Virginia, United States
Scottsdale, Arizona, United States
Roanoke, Virginia, United States
Huntsville, Alabama, United States
Delray Beach, Florida, United States
Bethlehem, Pennsylvania, United States
Charleston, West Virginia, United States
Charleston, South Carolina, United States
Norfolk, Virginia, United States
Charlotte, North Carolina, United States
La Jolla, California, United States
Ocala, Florida, United States
La Mesa, California, United States
Urbana, Illinois, United States
Tucson, Arizona, United States
Cumming, Georgia, United States
Evansville, Indiana, United States
Bay City, Michigan, United States
Houston, Texas, United States
Grand Rapids, Michigan, United States
Harrisburg, Pennsylvania, United States
Lafayette, Louisiana, United States
New York City, New York, United States
Sugarland, Texas, United States
Patients applied
Trial Officials
Meghan Dermody, MD
Principal Investigator
Lancaster General Hospital
Jeffrey Jim, MD
Principal Investigator
Abbott Northwestern Minneapolis Heart Institute Foundation
Marc Schermerhorn, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported