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

NCT05365490 | Completed FDA Device

• 1 other identifier: SRM-2022-01
• Study Type: observational
• Target: 344
• Locations: 1 country
• Sites: 53

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

Conditions

Carotid Artery Diseases

Outcome Measures

Primary Outcomes (2)

• 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

  within 30 days of the index procedure

• Ipsilateral Stroke

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

  within 31 to 365 days following the index procedure

Secondary Outcomes (13)

• Incidence of cranial nerve injury

  within 30 days of the index procedure

• Stroke

  within 30 days of the index procedure

• Death

  within 30 days of the index procedure

• MI

  within 30 days of the index procedure

• Stroke/Death/MI

  within 30 days of the index procedure

Study Arms (1)

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.

Procedure: Transcarotid Artery Revascularization (TCAR)

Interventions

Transcarotid Artery Revascularization (TCAR) PROCEDURE

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

Also known as: Carotid Revascularization, Carotid Artery Stenting

Standard-risk patients requiring carotid intervention

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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
• 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).
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Silk Road Medical: lead

Study Sites (53)

Valley Vascular Consultants

Huntsville, Alabama, 35801, United States

Location

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Pima Heart & Vascular

Tucson, Arizona, 85718, United States

Location

University of California, San Diego (UCSD)

La Jolla, California, 92037, United States

Location

Sharp Grossmont

La Mesa, California, 91942, United States

Location

University of California, Los Angeles (UCLA)

Los Angeles, California, 90024, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

AdventHealth Ocala

Ocala, Florida, 34471, United States

Location

Coastal Vascular & Interventional

Pensacola, Florida, 32504, United States

Location

Northside Vascular

Cumming, Georgia, 30342, United States

Location

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

Carle Health

Urbana, Illinois, 61801, United States

Location

Deaconess Research / Evansville Surgical Associates

Evansville, Indiana, 47710, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Baton Rouge General

Baton Rouge, Louisiana, 70809, United States

Location

Acadiana Vascular Clinic / Our Lady Lourdes Heart Hospital

Lafayette, Louisiana, 70508, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

McLaren Heart & Vascular

Bay City, Michigan, 48708, United States

Location

Corewell Health

Grand Rapids, Michigan, 49503, United States

Location

Abbott Northwestern

Minneapolis, Minnesota, 55407, United States

Location

St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

Midwest Aortic & Vascular Institute

North Kansas City, Missouri, 64116, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

New York University

New York, New York, 10016, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

University of Rochester

Rochester, New York, 14623, United States

Location

Atrium Health

Charlotte, North Carolina, 28203, United States

Location

Duke University

Raleigh, North Carolina, 27710, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

St. Charles Health System

Bend, Oregon, 97701, United States

Location

Providence St. Vincent

Portland, Oregon, 97225, United States

Location

St. Luke's University Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

UPMC Pinnacle

Harrisburg, Pennsylvania, 17050, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29401, United States

Location

Stern Cardiovascular

Germantown, Tennessee, 38138, United States

Location

Cardiovascular Surgery Clinic

Memphis, Tennessee, 38120, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

Location

Baylor Scott & White Dallas

Dallas, Texas, 75146, United States

Location

Memorial Hermann Southeast

Houston, Texas, 77030, United States

Location

Baylor Scott & White Plano

Plano, Texas, 75093, United States

Location

Houston Methodist Sugarland

Sugarland, Texas, 77479, United States

Location

Sentara

Norfolk, Virginia, 23507, United States

Location

Carilion Roanoke Memorial

Roanoke, Virginia, 24014, United States

Location

Charleston Area Medical Center (CAMC)

Charleston, West Virginia, 25304, United States

Location

Related Publications (3)

• 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.

  PMID: 32941280 BACKGROUND

• 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.

  PMID: 31846015 BACKGROUND

• 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.

  PMID: 22821614 BACKGROUND

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 9, 2022
• Study Start: September 1, 2022
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (53)