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

NCT03982420 | Completed Results FDA Device

• 1 other identifier: SRM-2018-01
• Study Type: observational
• Target: 55
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Carotid Artery Diseases; Carotid Atherosclerosis; Carotid Stenosis; Carotid Artery Plaque; Carotid Disease

Outcome Measures

Primary Outcomes (2)

• Incidence of Ipsilateral New White Lesions, by Patient

  Number of Participants with new white lesions from baseline (pre-procedure) by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) between 12-60 hours after procedure end time up to 30 days post-procedure.

  Between 12-60 hours after procedure end time to 30 days post-procedure.

• Incidence of Ipsilateral Persistent Lesions, by Patient

  Number of participants at 30 day post-procedure with persistent ipsilateral new white lesions post-procedure by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI).

  30-days

Secondary Outcomes (5)

• All Stroke and Neurological Death

  0 to 30 days

• Volume of DW-MRI White Lesions

  30-days

• Location of DW-MRI Lesions

  30-day

• Stroke/Neurological Death in Patients Eligible and Ineligible for ROADSTER 2

  0 to 30-day

• Rate of Contralateral New White Lesions by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), by Patient

  30-day

Interventions

Transcarotid Revascularization (TCAR) PROCEDURE

Carotid 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

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 participating in this evaluation will be comprised of male and female symptomatic or asymptomatic patients requiring carotid revascularization.

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.

Sponsors & Collaborators

• Silk Road Medical: lead

Study Sites (6)

Yale University

New Haven, Connecticut, 06519, United States

Location

Indiana University, Vascular Surgery

Indianapolis, Indiana, 46202, United States

Location

Newton Wellesley Hospital

Newton, Massachusetts, 95110, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Clinica Universidad de Navarra

Madrid, 28022, Spain

Location

MeSH Terms

Conditions

Carotid Artery Diseases; Carotid Stenosis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Modest sample size. Not powered for formal hypothesis testing or subgroup comparisons. No comparator arm with CEA or TF-CAS to enabled direct comparisons. Variability in contrast injection technique may influence lesion detection. Power injection was recommended but not universally followed.

Results Point of Contact

• Title: Megan White
• Organization: Boston Scientific

Megan.White2@bsci.com

(763) 494-1700

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 11, 2019
• Study Start: June 27, 2019
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: January 14, 2026
• Results First Posted: January 14, 2026

Record last verified: 2026-01

Locations

US (5); ES (1)