POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE

NCT02536378 | Completed Results

• 1 other identifier: SRM-2015-02
• Study Type: observational
• Target: 692
• Locations: 3 countries
• Sites: 43

Brief Summary

The ROADSTER 2 Study is intended to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the transcarotid technique.

Conditions

Carotid Artery Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Procedural Success

  Procedural success is defined as acute device success (successful insertion of the ENROUTE NPS and establishment of flow reversal), technical success (deployment of interventional tools) and the absence of a major adverse events (hierarchical stroke/death/myocardial infarction) through 30 days.

  30 Days

Secondary Outcomes (4)

• Number of Participants Experiencing Major Adverse Event

  30 days

• Number of Participants With Acute Device Success

  2 hours (periprocedural)

• Number of Participants With Technical Success

  2 hours (periprocedural)

• Number of Participants in Which a Cranial Nerve Injury Occurred

  90 days (extended follow-up)

Eligibility Criteria

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

Study Population

Patients with atherosclerotic extracranial internal carotid stenosis (ICA) with or without involvement of the contiguous common artery (CCA) determined by duplex ultrasound, CT/CTA, MR/MRA or angiography to be: * Symptomatic: greater than or equal to 50% stenosis or * Asymptomatic: greater than or equal to 80% stenosis

You may qualify if:

• Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:
• Symptomatic: Stenosis must be \>50% as determined by an angiogram and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS ≤2), TIA and/or amaurosis fugax within 180 days of the procedure procedure ipsilateral to the carotid artery to be stented.
• OR Asymptomatic: Stenosis must be \>80% as determined by angiogram without any neurological symptoms within the prior 180 days.
• Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and ENROUTE Stent System (refer to IFU for requirements).
• Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
• Patient is ≥18 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/Ethics Committee of the respective clinical site prior to the 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.
• Patient must have a life expectancy ≥ 3 years at the time of the index procedure without contingencies related to other medical, surgical or endovascular intervention.
• Patient meets at least one of the surgical high-risk criteria listed below.
• A. Contralateral carotid artery occlusion B. Tandem stenoses \>70% C. High cervical carotid artery stenosis D. Restenosis after carotid endarterectomy E. Bilateral carotid artery stenosis requiring treatment within 30 days after index treatment.
• F. Hostile Necks which the Investigator deems safe for transcarotid access including but not limited to:
• I. Prior neck irradiation II. Radical neck dissection III. Cervical spine immobility
• G. Patient is \> 75 years of age H. Patient has \> 2-vessel coronary artery disease and history of angina of any severity I. Patient has a history of angina
• Canadian Cardiovascular Society (CCS) angina class 3 or 4 or

You may not qualify if:

• Patient has an alternative source of cerebral embolus, including but not limited to:
• Patient has chronic atrial fibrillation.
• Patient has had 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 emboli. e.g. 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).
• Recently (\<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.
• Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by 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 attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS ≥ 5 OR mRS ≥ 3) likely to confound study endpoints within 1 month of index procedure.
• Patient has an intracranial tumor.
• Patient has an evolving stroke.
• Patient has neurologic illnesses within the past two 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 CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.

Sponsors & Collaborators

• Silk Road Medical: lead

Study Sites (43)

Peter Morton UCLA Medical Center

Los Angeles, California, 90095, United States

Location

MedStar Washington Hospital Center

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

Location

Emory Healthcare

Atlanta, Georgia, 30322, United States

Location

Kaiser Permanente, Hawaii

Honolulu, Hawaii, 96819, United States

Location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Unity Point Health - Iowa Clinic

Des Moines, Iowa, 50309, United States

Location

Baptist Health Louisville

Louisville, Kentucky, 40207, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

John Hopkins

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel

Boston, Massachusetts, 02215, United States

Location

St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

Location

Michigan Vascular Center

Flint, Michigan, 48507, United States

Location

Abbott Northwestern

Minneapolis, Minnesota, 55407, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Dartmouth Hitchcock Medical Ct.

Lebanon, New Hampshire, 03756, United States

Location

New Mexico

Albuquerque, New Mexico, 87102, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Sisters of Charity Hospital

Buffalo, New York, 14214, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

New Your Presbytarian - Weill Cornell

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14623, United States

Location

Stony Brook Medicine

Stony Brook, New York, 11794, United States

Location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

University Hospitals Case Medical Center and Case Western Reserve University School of Medicine

Cleveland, Ohio, 44106, United States

Location

Oklahoma Heart

Oklahoma City, Oklahoma, 73120, United States

Location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18018, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

UPMC (University of Pittsburgh Medical Center)

Pittsburgh, Pennsylvania, 15213, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

Location

Houston Methodist DeBakey Heart & Vascular Center

Houston, Texas, 77030, United States

Location

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

Sentara Vascular Specialists

Chesapeake, Virginia, 23320, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

CAMC Clinical Trials Center

Charleston, West Virginia, 25304, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Technical University Munich

Munich, 81675, Germany

Location

Hospital Quirónsalud Marbella

Marbella, 29603, Spain

Location

Related Publications (4)

• Alpaslan A, Wintermark M, Pinter L, Macdonald S, Ruedy R, Kolvenbach R. Transcarotid Artery Revascularization With Flow Reversal. J Endovasc Ther. 2017 Apr;24(2):265-270. doi: 10.1177/1526602817693607. Epub 2017 Feb 17.

  PMID: 28335706 RESULT

• Chung J, Kumins NH, Smith J, Motaganahalli RL, Schneider PA, Kwolek CJ, Kashyap VS; ROADSTER Investigators. Physiologic risk factors increase risk of myocardial infarction with transcarotid artery revascularization in prospective trials. J Vasc Surg. 2023 Apr;77(4):1192-1198. doi: 10.1016/j.jvs.2022.12.013. Epub 2022 Dec 20.

  PMID: 36563712 DERIVED

• Kashyap VS, So KL, Schneider PA, Rathore R, Pham T, Motaganahalli RL, Massop DW, Foteh MI, Eckstein HH, Jim J, Leal Lorenzo JI, Melton JG. One-year outcomes after transcarotid artery revascularization (TCAR) in the ROADSTER 2 trial. J Vasc Surg. 2022 Aug;76(2):466-473.e1. doi: 10.1016/j.jvs.2022.03.872. Epub 2022 Apr 2.

  PMID: 35381327 DERIVED

• Kashyap VS, Schneider PA, Foteh M, Motaganahalli R, Shah R, Eckstein HH, Henao S, LaMuraglia G, Stoner MC, Melton J, Massop D, Hanover T, Titus J, Moore WS, Rodriguez-Carvajal R, Malas MB, Arko FR 3rd, Pierce D, Anain P, Oskin T; ROADSTER 2 Investigators*. Early Outcomes in the ROADSTER 2 Study of Transcarotid Artery Revascularization in Patients With Significant Carotid Artery Disease. Stroke. 2020 Sep;51(9):2620-2629. doi: 10.1161/STROKEAHA.120.030550. Epub 2020 Aug 19.

  PMID: 32811386 DERIVED

Related Links

• Transcarotid Artery Revascularization With Flow Reversal: The PROOF Study

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ric Ruedy, Executive VP, Clinical, Regulatory and Quality Affairs
• Organization: Silk Road Medical, Inc.

ric@silkroadmed.com

408-585-2112

Study Officials

• Vikram Kashyap, MD

  University Hospital Case Medical Center Harrington Heart & Vascular Institute

  PRINCIPAL INVESTIGATOR

• Peter Schneider, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: August 31, 2015
• Study Start: October 23, 2015
• Primary Completion: April 29, 2019
• Study Completion: April 29, 2019
• Last Updated: July 29, 2020
• Results First Posted: July 29, 2020

Record last verified: 2020-07

Locations

ES (1); US (41); DE (1)