The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation

Completed

Conditions studied: Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Stenosis, Carotid Artery Plaque, Carotid Disease

In brief

The goal of this evaluation is to document the incidence of post procedure DW-MRI lesions (relative to baseline) in patients treated with the transcarotid artery revascularization (TCAR) procedure.

Key facts

Study ID

NCT03982420

Run by

Silk Road Medical

People needed

55

Starts

2019-06-27

Expected to finish

2022-01-19

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stenosis must be >50% as determined by ultrasound or angiogram1 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 ipsilateral to the carotid artery to be stented.
• Stenosis must be >80% as determined by ultrasound or angiogram without any neurological symptoms within the prior 180 days.
• Target vessel must meet diameter requirements for stent (refer to stent IFU for diameter 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 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 in CMS National Coverage Determination (NCD) for Percutaneous Transluminal Angioplasty (20.7)

You may not qualify if…

• Alternative source of cerebral embolus
• 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 (less than one-third middle cerebral artery volume).
• 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 evolving stroke.
• Patient has an intracranial tumor.
• 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 defined as the ipsilateral middle cerebral artery being supplied only by the ipsilateral internal carotid artery.
• Patient has active bleeding diathesis or coagulopathy or will refuse blood transfusion.
• 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.
• Occlusion 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.
• Patients with carotid string sign (a very high-grade carotid stenosis to the skull base with a long, thin, barely visible string of contrast within the true lumen of the artery.).
• Ostium of Common Carotid Artery (CCA) requires revascularization (>50% stenosis).
• Patient has an open stoma in the neck.
• Patients with hostile necks due to prior neck irradiation
• Female patients who are 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, prasugrel, statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine, ASA and clopidogrel or ASA and prasugrel.

Where it is running

• Yale University — New Haven, Connecticut, United States
• Indiana University, Vascular Surgery — Indianapolis, Indiana, United States
• Newton Wellesley Hospital — Newton, Massachusetts, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Clinica Universidad de Navarra — Madrid, Spain

Full record on ClinicalTrials.gov

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