Carotid Artery DiseasesNCT06470815
ROADSTER 3 Extended Follow-up Sub-Study
An observational study of Carotid Artery Diseases, run by Silk Road Medical at 37 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Carotid Artery Diseases
- What is being tested?
- Transcarotid Artery Revascularization (TCAR)
- Type of treatment
- Surgery or procedure
- How many people
- 197 participants
- Where
- 37 sitesUnited States
- Study dates
- 31 Jul 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who were enrolled in the ROADSTER 3 study
Who may be able to join
- Participants who were enrolled in the ROADSTER 3 study and treated with the ENROUTE TSS and ENROUTE NPS
- Able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78756
McLaren Heart & Vascular
Bay City, Michigan, 48708
St. Luke's University Hospital
Bethlehem, Pennsylvania, 18015
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29401
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, 25304
St. Luke's Hospital
Chesterfield, Missouri, 63017
Bethesda North Hospital
Cincinnati, Ohio, 45242
Morton Plant Hospital
Clearwater, Florida, 33756
Northside Vascular
Cumming, Georgia, 30342
Delray Medical Center
Delray Beach, Florida, 33484
Deaconess Research / Evansville Surgical Associates
Evansville, Indiana, 47710
Corewell Health
Grand Rapids, Michigan, 49503
Hackensack University Medical Center
Hackensack, New Jersey, 07601
UPMC Pinnacle
Harrisburg, Pennsylvania, 17050
Memorial Hermann Southeast
Houston, Texas, 77030
Valley Vascular Consultants
Huntsville, Alabama, 35801
Indiana University
Indianapolis, Indiana, 46202
University of California, San Diego (UCSD)
La Jolla, California, 92037
Sharp Grossmont
La Mesa, California, 91942
Acadiana Vascular Clinic / Our Lady Lourdes Heart Hospital
Lafayette, Louisiana, 70508
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Abbott Northwestern
Minneapolis, Minnesota, 55407
New York University
New York, New York, 10016
The Mount Sinai Hospital
New York, New York, 10029
Sentara
Norfolk, Virginia, 23507
AdventHealth Ocala
Ocala, Florida, 34471
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Maine Medical Center
Portland, Maine, 04102
Providence Portland Medical Center-Hospital
Portland, Oregon, 97213
Carilion Roanoke Memorial
Roanoke, Virginia, 24014
University of Rochester
Rochester, New York, 14623
HonorHealth
Scottsdale, Arizona, 85258
Houston Methodist Sugarland
Sugarland, Texas, 77479
Pima Heart & Vascular
Tucson, Arizona, 85718
About this study
Official title: 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).
Read the 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.
- Conditions
- Carotid Artery Diseases
- Being tested
- Transcarotid Artery Revascularization (TCAR)
- Keywords
- Long-term Follow-up, TCAR
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcarotid Artery Revascularization (TCAR)Procedure or surgery
Also called Carotid Revascularization, Carotid Artery Stenting
Carotid artery revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Transcarotid Artery Revascularization (TCAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral Stroke
Ipsilateral stroke at 2-years, 3-years, 4-years, and 5-years following the index procedure
Measured: 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
Measured: 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
Measured: 2-years and 5-years following the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start31 Jul 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Why it stopped: The decision to close the study is not related to any safety concerns or newly identified risks to patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silk Road Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meghan Dermody, MD, Principal investigator, Lancaster General HospitalJeffrey Jim, MD, Principal investigator, Abbott Northwestern Minneapolis Heart Institute FoundationMarc Schermerhorn, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470815
- Sponsor's protocol ID
- SRM-2024-01
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-up Study of ROADSTER 3 Patients
- ClinicalTrials.gov ID
- NCT06470815
- Acronym / sponsor ID
- SRM-2024-01
- Conditions
- Carotid Artery Diseases
- Keywords
- Long-term Follow-up, TCAR
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The decision to close the study is not related to any safety concerns or newly identified risks to patients.
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Silk Road MedicalIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard-risk patients who underwent carotid intervention | – | Procedure: Transcarotid Artery Revascularization (TCAR)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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who were enrolled in the ROADSTER 3 study
Key inclusion criteria (2 listed)
- Participants who were enrolled in the ROADSTER 3 study and treated with the ENROUTE TSS and ENROUTE NPS
- Able to provide informed consent
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcarotid Artery Revascularization (TCAR)Also: Carotid Revascularization, Carotid Artery StentingCarotid artery revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent | Procedure or surgery | Standard-risk patients who underwent carotid intervention |
Primary outcome
Ipsilateral Stroke
Time frame: 2-years, 3-years, 4-years, and 5-years following the index procedure
Ipsilateral stroke at 2-years, 3-years, 4-years, and 5-years following the index procedure
Ipsilateral Stroke Mortality
Time frame: 2-years, 3-years, 4-years, and 5-years following the index procedure
Ipsilateral stroke mortality at 2-years, 3-years, 4-years, and 5-years following the index procedure
In-stent Restenosis
Time frame: 2-years and 5-years following the index procedure
In-stent restenosis ≥70% at 2-years and 5-years
Results and safety
The study was stopped early (reason given: The decision to close the study is not related to any safety concerns or newly identified risks to patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Diseases, run by Silk Road Medical at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The decision to close the study is not related to any safety concerns or newly identified risks to patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ipsilateral Stroke (time frame: 2-years, 3-years, 4-years, and 5-years following the index procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.