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

Completed

Conditions: Carotid Artery Disease

Registration Number: NCT02536378

Lead Sponsor: Silk Road Medical

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 692

Inclusion Criteria

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

Clinical High Risk Inclusion Criteria:

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
unstable angina

J. Patient has congestive heart failure (CHF) - New York Heart Association (NYHA)

Functional Class III or IV

K. Patient has known severe left ventricular dysfunction

LVEF <30%.

L. Patient has had a myocardial infarction > 72 hours and < 6 weeks prior to procedure.

M. Patient has severe pulmonary disease (COPD) with either:

FEV1 <50% predicted or
chronic oxygen therapy or
resting PO2 of <60 mmHg (room air)

N. Patient has permanent contralateral cranial nerve injury O. Patient has chronic renal insufficiency (serum creatinine > 2.5 mg/dL).

REMINDER: The following is a list of anatomical considerations that are not suitable for transfemoral CAS with distal protection that are NOT contraindications for enrollment in the ROADSTER 2 Study including but not limited to:

I. TypeII, III, or Bovine arch II. Arch atheroma or calcification III. Atheroma of the great vessel origins IV. Tortuous distal ICA V. Tortuous or occluded iliofemoral segments VI. Occluded aortoiliac segments

EXCLUSION CRITERIA:

Each potential patient must be screened to ensure that they do not meet any of the following exclusion criteria. This screening is to be based on known medical history and data available at the time of eligibility determination and enrollment.

Patient has an alternative source of cerebral embolus, including but not limited to:
1. Patient has chronic atrial fibrillation.
2. Patient has had 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 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).
4. Recently (<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.
5. 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.
Myocardial Infarction within 72 hours prior to the intervention.
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 Common Carotid Artery (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 stent IFU), including aspirin (ASA), ticlopidine, clopidogrel, statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine or ASA and clopidogrel.
Patient must have a life expectancy <3 years without contingencies related to other medical, surgical, or interventional procedures as per the Wallaert Score and patients with primary, recurrent or metastatic malignancy who do not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Procedural Success	30 Days	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Major Adverse Event	30 days	Secondary endpoints include the 30-day rate of hierarchical stroke, death or myocardial infarction, the rate of hierarchical stroke, death or myocardial infarction by symptom status, the rate of cardiac death and the rate of neurological death.
Number of Participants With Acute Device Success	2 hours (periprocedural)	Acute device success is defined as the ability to insert the device, establish flow reversal, and remove the device
Number of Participants With Technical Success	2 hours (periprocedural)	Technical success is defined as acute device success plus the ability to deliver interventional tools
Number of Participants in Which a Cranial Nerve Injury Occurred	90 days (extended follow-up)	Rate of cranial nerve injury suspected to be caused by surgical procedure and adjudicated by CEC.

Trial Locations

Locations (43): Peter Morton UCLA Medical Center
🇺🇸
Los Angeles, California, United States
Eastern Maine Medical Center
🇺🇸
Bangor, Maine, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University Hospitals Case Medical Center and Case Western Reserve University School of Medicine
🇺🇸
Cleveland, Ohio, United States
Indiana University Health Methodist Hospital
🇺🇸
Indianapolis, Indiana, United States
Houston Methodist DeBakey Heart & Vascular Center
🇺🇸
Houston, Texas, United States
MedStar Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Emory Healthcare
🇺🇸
Atlanta, Georgia, United States
John Hopkins
🇺🇸
Baltimore, Maryland, United States
St. Elizabeth's Medical Center
🇺🇸
Brighton, Massachusetts, United States
Beth Israel
🇺🇸
Boston, Massachusetts, United States
Michigan Vascular Center
🇺🇸
Flint, Michigan, United States
Abbott Northwestern
🇺🇸
Minneapolis, Minnesota, United States
Dartmouth Hitchcock Medical Ct.
🇺🇸
Lebanon, New Hampshire, United States
Albany Medical Center
🇺🇸
Albany, New York, United States
Sisters of Charity Hospital
🇺🇸
Buffalo, New York, United States
Stony Brook Medicine
🇺🇸
Stony Brook, New York, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
New Your Presbytarian - Weill Cornell
🇺🇸
New York, New York, United States
Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
UPMC (University of Pittsburgh Medical Center)
🇺🇸
Pittsburgh, Pennsylvania, United States
St. Luke's University Health Network
🇺🇸
Bethlehem, Pennsylvania, United States
Michael E DeBakey VA Medical Center
🇺🇸
Houston, Texas, United States
Wellmont CVA Heart Institute
🇺🇸
Kingsport, Tennessee, United States
Greenville Hospital System
🇺🇸
Greenville, South Carolina, United States
Scott and White Memorial Hospital
🇺🇸
Temple, Texas, United States
CAMC Clinical Trials Center
🇺🇸
Charleston, West Virginia, United States
Virginia Mason Medical Center
🇺🇸
Seattle, Washington, United States
Sentara Vascular Specialists
🇺🇸
Chesapeake, Virginia, United States
Technical University Munich
🇩🇪
Munich, Germany
Hospital Quirónsalud Marbella
🇪🇸
Marbella, Spain
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States
Kaiser Permanente, Hawaii
🇺🇸
Honolulu, Hawaii, United States
Baptist Health Louisville
🇺🇸
Louisville, Kentucky, United States
University of Wisconsin
🇺🇸
Madison, Wisconsin, United States
Unity Point Health - Iowa Clinic
🇺🇸
Des Moines, Iowa, United States
New Mexico
🇺🇸
Albuquerque, New Mexico, United States
University of Rochester
🇺🇸
Rochester, New York, United States
University of North Carolina, Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
Oklahoma Heart
🇺🇸
Oklahoma City, Oklahoma, United States
Cardiothoracic and Vascular Surgeons
🇺🇸
Austin, Texas, United States
Thomas Jefferson University
🇺🇸
Philadelphia, Pennsylvania, United States