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

NCT ID: NCT05365490

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 344 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2025-07-22

Brief 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

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.

Conditions

Carotid Artery Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Standard-risk patients requiring 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 require carotid artery revascularization.

Transcarotid Artery Revascularization (TCAR)

Intervention Type: PROCEDURE

Carotid artery revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent

Interventions

Transcarotid Artery Revascularization (TCAR)

Carotid artery revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent

Intervention Type: PROCEDURE

Other Intervention Names

Carotid Revascularization; Carotid Artery Stenting

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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

3. Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and ENROUTE Stent System (refer to IFU for requirements).

4. Patient is ≥18 and <80 years of age.

5. 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.

6. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.

Exclusion Criteria

1. Patient meets any of the surgical high-risk criteria listed below.

• 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
• 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

• 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

2. Patient has an alternative source of cerebral embolus, including but not limited to:

1. Chronic atrial fibrillation.

2. Any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.

3. 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).

4. Recently implanted heart valve (either surgically or endovascularly) within 60 days prior to index procedure with confirmed emboli on echocardiogram.

5. 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.

3. 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.

4. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.

5. 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).

6. Patient has an intracranial tumor.

7. Patient has an evolving stroke.

8. 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.

9. Patient has had a TIA or amaurosis fugax within 48 hrs. prior to the procedure

10. Patient has an isolated hemisphere

11. 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.

12. Presence of a previous placed intravascular stent in target vessel or ipsilateral CCA or significant CCA inflow lesion.

13. Occlusion or [Thrombolysis in Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery.

14. 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.

15. Ostium of CCA requires revascularization.

16. Patient has an open stoma in the neck.

17. Female patients who are pregnant or may become pregnant.

18. 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..

19. 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.

20. 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.

21. Patient has an unresolved/uncorrected bleeding disorder.

22. Patient has a known allergy to nitinol

23. 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Silk Road Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meghan Dermody, MD

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Jeffrey Jim, MD

Role: PRINCIPAL_INVESTIGATOR

Abbott Northwestern Minneapolis Heart Institute Foundation

Marc Schermerhorn, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Valley Vascular Consultants

Huntsville, Alabama, United States

HonorHealth

Scottsdale, Arizona, United States

Pima Heart & Vascular

Tucson, Arizona, United States

University of California, San Diego (UCSD)

La Jolla, California, United States

Sharp Grossmont

La Mesa, California, United States

University of California, Los Angeles (UCLA)

Los Angeles, California, United States

Yale University

New Haven, Connecticut, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Morton Plant Hospital

Clearwater, Florida, United States

Delray Medical Center

Delray Beach, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

AdventHealth Ocala

Ocala, Florida, United States

Coastal Vascular & Interventional

Pensacola, Florida, United States

Northside Vascular

Cumming, Georgia, United States

Alexian Brothers Medical Center

Elk Grove Village, Illinois, United States

Carle Health

Urbana, Illinois, United States

Deaconess Research / Evansville Surgical Associates

Evansville, Indiana, United States

Indiana University

Indianapolis, Indiana, United States

Baton Rouge General

Baton Rouge, Louisiana, United States

Acadiana Vascular Clinic / Our Lady Lourdes Heart Hospital

Lafayette, Louisiana, United States

Maine Medical Center

Portland, Maine, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

McLaren Heart & Vascular

Bay City, Michigan, United States

Corewell Health

Grand Rapids, Michigan, United States

Abbott Northwestern

Minneapolis, Minnesota, United States

St. Luke's Hospital

Chesterfield, Missouri, United States

Midwest Aortic & Vascular Institute

North Kansas City, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Long Island Jewish Medical Center

New Hyde Park, New York, United States

New York University

New York, New York, United States

The Mount Sinai Hospital

New York, New York, United States

University of Rochester

Rochester, New York, United States

Atrium Health

Charlotte, North Carolina, United States

Duke University

Raleigh, North Carolina, United States

Bethesda North Hospital

Cincinnati, Ohio, United States

St. Charles Health System

Bend, Oregon, United States

Providence St. Vincent

Portland, Oregon, United States

St. Luke's University Hospital

Bethlehem, Pennsylvania, United States

UPMC Pinnacle

Harrisburg, Pennsylvania, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Stern Cardiovascular

Germantown, Tennessee, United States

Cardiovascular Surgery Clinic

Memphis, Tennessee, United States

Cardiothoracic and Vascular Surgeons

Austin, Texas, United States

Baylor Scott & White Dallas

Dallas, Texas, United States

Memorial Hermann Southeast

Houston, Texas, United States

Baylor Scott & White Plano

Plano, Texas, United States

Houston Methodist Sugarland

Sugarland, Texas, United States

Sentara

Norfolk, Virginia, United States

Carilion Roanoke Memorial

Roanoke, Virginia, United States

Charleston Area Medical Center (CAMC)

Charleston, West Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 32941280 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31846015 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22821614 (View on PubMed)

Other Identifiers

SRM-2022-01

Identifier Type: -

Identifier Source: org_study_id