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Carotid Artery DiseasesNCT05365490

Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease

An observational study of Carotid Artery Diseases, run by Silk Road Medical at 53 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study objective is to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System in patients at standard risk for adverse events from carotid endarterectomy 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
344 participants
Where
53 sitesUnited States
Study dates
1 Sep 2022to 22 Jul 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: Patient with discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA) determined by duplex ultrasound, CT/CTA, MR/MRA or angiography. -Symptomatic: ≥70% stenosis of the common or internal carotid artery by ultrasound or ≥50% stenosis of the common or internal carotid artery by angiogram Or -Asymptomatic: ≥70% stenosis of the common or internal carotid artery by ultrasound or ≥60% stenosis of the common or internal carotid artery by angiogram

Who may be able to join

  • Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA) determined by duplex ultrasound, CT/CTA, MR/MRA or angiography.
  • Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:
  • Symptomatic: ≥70% stenosis of the common or internal carotid artery by ultrasound or ≥50% stenosis of the common or internal carotid artery by angiogram
  • OR
  • Asymptomatic: ≥70% stenosis of the common or internal carotid artery by ultrasound or ≥60% stenosis of the common or internal carotid artery by angiogram
  • Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and ENROUTE Stent System (refer to IFU for requirements).
Show all 9Show fewer
  • Patient is ≥18 and <80 years of age.
  • Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Institutional Review Board of the respective clinical site prior to the study procedure. This will be obtained prior to participation in the study.
  • Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.

Who cannot join

  • Patient meets any of the surgical high-risk criteria listed below.
  • Anatomic high risk exclusion criteria:
  • Contralateral carotid artery occlusion
  • Tandem stenoses in the ICA >70% diameter reducing
  • High cervical carotid artery stenosis above the C2 vertebra
  • Restenosis after prior ipsilateral carotid endarterectomy
Show all 48Show fewer
  • Bilateral carotid artery stenosis requiring treatment within 30 days after index procedure
  • Hostile Necks including prior neck irradiation, radical neck dissection, and cervical spine immobility
  • Clinical high risk exclusion criteria:
  • Patient is ≥80 years of age
  • Patient has ≥2-vessel coronary artery disease (or has had revascularization procedure within the last 30 days) and/or angina
  • Patient has history of unresolved angina - Canadian Cardiovascular Society (CCS) angina class 3 or 4 OR unstable angina
  • Patient has congestive heart failure (CHF) - New York Heart Association (NYHA) Functional Class III or IV
  • Patient has a known severe left ventricular dysfunction - LVEF <30%
  • Patient has had a myocardial infarction within 6 weeks prior to the procedure
  • Patient has severe obstructive pulmonary disease (COPD) with either:
  • FEVI <50% predicted OR
  • chronic oxygen therapy OR
  • resting PO2 of ≤60 mmHG (room air)
  • Patient has permanent contralateral cranial and/or laryngeal nerve injury
  • Patient has chronic renal insufficiency (serum creatinine ≥2.5 mg/dL) or is on dialysis
  • Patient has an alternative source of cerebral embolus, including but not limited to:
  • Chronic atrial fibrillation.
  • Any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.
  • Knowledge of cardiac sources of thrombus. (If patient has left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma AND there is no confirmed thrombus on an echocardiogram performed within 3 months prior to index procedure, the patient may be eligible for enrollment).
  • Recently implanted heart valve (either surgically or endovascularly) within 60 days prior to index procedure with confirmed emboli on echocardiogram.
  • Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by pre-procedure angiography or CTA/MRA ≤6 months prior to index procedure) greater in severity than the lesion to be treated, cerebral aneurysm >5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.
  • Patient has a history of spontaneous intracranial hemorrhage within the past 12 months or has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure.
  • Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.
  • Patient with a history of major stroke prior to the TCAR procedure attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS ≥5 OR mRS ≥3) likely to confound study endpoints 1 month after the TCAR procedure (because the deficit persists post-operatively).
  • Patient has an intracranial tumor.
  • Patient has an evolving stroke.
  • Patient has neurologic illnesses within the past 2 years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke, including but not limited to: moderate to severe dementia, partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, or intracranial hemorrhage.
  • Patient has had a TIA or amaurosis fugax within 48 hrs. prior to the procedure
  • Patient has an isolated hemisphere
  • Patient had or will have open heart (e.g., CABG), endovascular stent procedure, valve intervention, vascular surgery, other major operation within 30 days of the index procedure.
  • Presence of a previous placed intravascular stent in target vessel or ipsilateral CCA or significant CCA inflow lesion.
  • Occlusion or [Thrombolysis in Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery.
  • An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) whether or not it is associated with an ulcerated target lesion.
  • Ostium of CCA requires revascularization.
  • Patient has an open stoma in the neck.
  • Female patients who are pregnant or may become pregnant.
  • Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to ENROUTE stent IFU), including aspirin (ASA), ticlopidine, clopidogrel, statin or contrast media (that cannot be pre-medicated). Patients must be able to tolerate statins (or a permitted non-statin substitute) and a combination of ASA and ticlopidine or ASA and clopidogrel or alternative P2Y12 inhibitor..
  • Patient has a life expectancy <5 years without contingencies related to other medical, surgical, or interventional procedures or is at High Risk as per the Wallaert Score. Estimation of life expectancy and scoring per the Wallaert Score is to be performed prior to enrollment.
  • Patient has primary, recurrent or metastatic malignancy and does not have independent assessment of life expectancy of ≥5 years performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.
  • Patient has an unresolved/uncorrected bleeding disorder.
  • Patient has a known allergy to nitinol
  • Patient is known to have an active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or has been previously diagnosed with COVID-19 with neurological sequelae that could confound endpoint assessments (e.g., baseline mRS>3).

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

United States53 sites

  • Cardiothoracic and Vascular Surgeons

    Austin, Texas, 78756

  • Baton Rouge General

    Baton Rouge, Louisiana, 70809

  • McLaren Heart & Vascular

    Bay City, Michigan, 48708

  • St. Charles Health System

    Bend, Oregon, 97701

  • 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

  • Atrium Health

    Charlotte, North Carolina, 28203

  • St. Luke's Hospital

    Chesterfield, Missouri, 63017

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Northside Vascular

    Cumming, Georgia, 30342

  • Baylor Scott & White Dallas

    Dallas, Texas, 75146

  • Delray Medical Center

    Delray Beach, Florida, 33484

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • Deaconess Research / Evansville Surgical Associates

    Evansville, Indiana, 47710

  • Stern Cardiovascular

    Germantown, Tennessee, 38138

  • 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

  • University of California, Los Angeles (UCLA)

    Los Angeles, California, 90024

  • Cardiovascular Surgery Clinic

    Memphis, Tennessee, 38120

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Abbott Northwestern

    Minneapolis, Minnesota, 55407

  • Yale University

    New Haven, Connecticut, 06519

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • New York University

    New York, New York, 10016

  • The Mount Sinai Hospital

    New York, New York, 10029

  • Sentara

    Norfolk, Virginia, 23507

  • Midwest Aortic & Vascular Institute

    North Kansas City, Missouri, 64116

  • AdventHealth Ocala

    Ocala, Florida, 34471

  • Coastal Vascular & Interventional

    Pensacola, Florida, 32504

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Baylor Scott & White Plano

    Plano, Texas, 75093

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence St. Vincent

    Portland, Oregon, 97225

  • Duke University

    Raleigh, North Carolina, 27710

  • 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

  • Carle Health

    Urbana, Illinois, 61801

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: Post-approval Study of Transcarotid Artery Revascularization in Standard Risk Patients With Significant Carotid Artery Disease. The ROADSTER 3 Study

The study objective is to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System in patients at standard risk for adverse events from carotid endarterectomy

Read the detailed description

This is an open label, single arm, multi-center post-approval study for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and who are eligible for treatment using the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid Neuroprotection System. The study will enroll a maximum of 400 patients treated per protocol at 30-60 sites in the United States.

Being tested
Transcarotid Artery Revascularization (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 groups in NCT05365490
Study groupRoleWhat they receive
Standard-risk patients requiring carotid interventionSymptomatic 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 require 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.

  1. Hierarchical composite of Major Adverse Events (MAEs)

    Hierarchical composite of Major Adverse Events (MAEs) defined as any death, stroke, or myocardial infarction within 30 days of the index procedure

    Measured: within 30 days of the index procedure

  2. Ipsilateral Stroke

    Ipsilateral stroke within 31 days to 365 days following the index procedure

    Measured: within 31 to 365 days following the index procedure

Secondary outcomes (13)

  1. Incidence of cranial nerve injury

    Incidence of cranial nerve injury within 30 days of the index procedure

    Measured: within 30 days of the index procedure

  2. Stroke

    Stroke within 30 days of the index procedure

    Measured: within 30 days of the index procedure

  3. Death

    Death within 30 days of the index procedure

    Measured: within 30 days of the index procedure

  4. MI

    MI within 30 days of the index procedure

    Measured: within 30 days of the index procedure

  5. Stroke/Death/MI

    Stroke/Death/MI within 30 days of the index procedure

    Measured: within 30 days of the index procedure

  6. Ipsilateral Stroke

    Ipsilateral stroke within 31 to 365 days of the index procedure

    Measured: 31-365 days

  7. Persistent cranial nerve injury

    Persistent cranial nerve injury at 6 months and 1 year

    Measured: at 6 months and 1 year

  8. Rate of hierarchical ipsilateral stroke, death, and myocardial infarction

    Rate of hierarchical ipsilateral stroke, death, and myocardial infarction within 30 days of the index procedure

    Measured: within 30 days of the index procedure

  9. Cardiac death

    Cardiac death at 1 year for patients who experienced an MI within 30 days of the index procedure

    Measured: 1 year

  10. Access site complications

    Access site complications (arterial/venous)

    Measured: within 30 days of the index procedure

  11. Serious Hematoma/Bleeding complications

    Serious Hematoma/Bleeding complications (arterial/venous)

    Measured: within 30 days of the index procedure

  12. Rate of stent thrombosis or occlusion

    Rate of stent thrombosis or occlusion within 30 days of the index procedure

    Measured: within 30 days of the index procedure

  13. Rate of dissection

    Rate of dissection within 30 days of the index procedure (during index procedure or a reintervention procedure)

    Measured: within 30 days of the index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2022
  2. Study start1 Sep 2022
  3. Primary completion22 Jul 2025
  4. Study completion22 Jul 2025

Resources

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
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05365490
Sponsor's protocol ID
SRM-2022-01
Status last verified
Jul 2025
First submitted
3 May 2022
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Not planning to share IPD

Publications

  • Malas MB, Dakour-Aridi H, Kashyap VS, Eldrup-Jorgensen J, Wang GJ, Motaganahalli RL, Cronenwett JL, Schermerhorn ML. TransCarotid Revascularization With Dynamic Flow Reversal Versus Carotid Endarterectomy in the Vascular Quality Initiative Surveillance Project. Ann Surg. 2022 Aug 1;276(2):398-403. doi: 10.1097/SLA.0000000000004496. Epub 2020 Sep 15.

    PubMed 32941280

  • Schermerhorn ML, Liang P, Eldrup-Jorgensen J, Cronenwett JL, Nolan BW, Kashyap VS, Wang GJ, Motaganahalli RL, Malas MB. Association of Transcarotid Artery Revascularization vs Transfemoral Carotid Artery Stenting With Stroke or Death Among Patients With Carotid Artery Stenosis. JAMA. 2019 Dec 17;322(23):2313-2322. doi: 10.1001/jama.2019.18441.

    PubMed 31846015

  • Vilain KR, Magnuson EA, Li H, Clark WM, Begg RJ, Sam AD 2nd, Sternbergh WC 3rd, Weaver FA, Gray WA, Voeks JH, Brott TG, Cohen DJ; CREST Investigators. Costs and cost-effectiveness of carotid stenting versus endarterectomy for patients at standard surgical risk: results from the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Stroke. 2012 Sep;43(9):2408-16. doi: 10.1161/STROKEAHA.112.661355. Epub 2012 Jul 19.

    PubMed 22821614

Questions about this trial

What is this clinical trial studying?

An observational study of Carotid Artery Diseases, run by Silk Road Medical at 53 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 9 inclusion and 48 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: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Hierarchical composite of Major Adverse Events (MAEs) (time frame: within 30 days of the index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05365490, which also lists 3 linked publications.

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 30 Jul 2025.

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