Carotid Artery DiseasesDW-MRI-USNCT03982420
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation
An observational study of Carotid Artery Diseases and Carotid Atherosclerosis, run by Silk Road Medical at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Stenosis
- What is being tested?
- Transcarotid Revascularization (TCAR)
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 27 Jun 2019to 19 Jan 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients participating in this evaluation will be comprised of male and female symptomatic or asymptomatic patients requiring carotid revascularization.
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
- Patient has a life expectancy <3 years with 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.
- Patient has had a recent GI bleed that would interfere with antiplatelet therapy.
- Patient is actively participating in an investigational drug or device trial (IND or IDE) that has not completed the required protocol follow-up period.
- Patient has inability to understand and cooperate with study procedures.
- Presence of extensive or diffuse atherosclerotic disease involving the proximal common carotid artery that would preclude the safe introduction of the study device.
- Patient is otherwise unsuitable for intervention in the opinion of the physician.
- Patients who cannot have MRI due to metallic implants (e.g. orthopedic implants, pacemakers, etc.)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Indiana University, Vascular Surgery
Indianapolis, Indiana, 46202
Yale University
New Haven, Connecticut, 06519
Newton Wellesley Hospital
Newton, Massachusetts, 95110
Stony Brook University Medical Center
Stony Brook, New York, 11794
About this study
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.
Read the detailed description
This is a prospective, single-arm, multi-center evaluation of patients requiring carotid revascularization who are treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent System. Both the ENROUTE Transcarotid NPS and ENROUTE Transcarotid Stent System have received CE mark and are commercially available in the European Union.
Patients enrolled in this study will have been offered the TCAR intervention as part of standard of care for the treatment of carotid artery stenosis, regardless of whether or not they agree to be in the study. Therefore, the act of participation in this procedure will not be the determining factor in whether or not the patient receives the TCAR treatment. Subject participation means they agree to undergo two additional DW-MRI imaging procedures immediately after the procedure and at 30 days to determine whether there is an increase in new white lesions. Any other procedure other than the active collection of consent and data by the sponsor is standard of care for the treatment of carotid artery stenosis.
These patients will be monitored to document the incidence of post procedure DW-MRI lesions (relative to baseline).
- Conditions
- Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Stenosis, Carotid Artery Plaque, Carotid Disease
- Being tested
- Transcarotid Revascularization (TCAR)
- Medical subject headings
- Carotid Artery Diseases, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcarotid Revascularization (TCAR)Procedure or surgery
Also called Carotid Revascularization, Carotid Artery Stenting
Carotid revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 30-days
Secondary outcomes (5)
All Stroke and Neurological Death
Number of Participants who experienced Stroke or Neurological death between 12-60 hours after procedure end time up to 30 days post-procedure.
Measured: 0 to 30 days
Volume of DW-MRI White Lesions
Volume of Persistent new white lesions post-procedure by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) at 30-Days.
Measured: 30-days
Location of DW-MRI Lesions
Number persistent new white lesions post-procedure by location by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) at 30-Days, categorized by location.
Measured: 30-day
Stroke/Neurological Death in Patients Eligible and Ineligible for ROADSTER 2
No patients enrolled in this study were enrolled in ROADSTER 2 trial; therefore, ROADSTER 2 specific endpoints were not evaluated.
Measured: 0 to 30-day
Rate of Contralateral New White Lesions by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), by Patient
Subjects with persistent contralateral new white lesions post-procedure by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), at 30-Days.
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start27 Jun 2019
- Primary completion19 Jan 2022
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silk Road Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982420
- Sponsor's protocol ID
- SRM-2018-01
- Acronym
- DW-MRI-US
- Status last verified
- Jan 2026
- First submitted
- 6 Jun 2019
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Results will be published following study end date.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation
- ClinicalTrials.gov ID
- NCT03982420
- Acronym / sponsor ID
- DW-MRI-US / SRM-2018-01
- Conditions
- Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Stenosis, Carotid Artery Plaque, Carotid Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Silk Road MedicalIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Posted 14 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-arm, multi-center evaluation of patients requiring carotid revascularization who are treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent System. Both the ENROUTE Transcarotid NPS and ENROUTE Transcarotid Stent System have received CE mark and are commercially available in the European Union.
Patients enrolled in this study will have been offered the TCAR intervention as part of standard of care for the treatment of carotid artery stenosis, regardless of whether or not they agree to be in the study. Therefore, the act of participation in this procedure will not be the determining factor in whether or not the patient receives the TCAR treatment. Subject participation means they agree to undergo two additional DW-MRI imaging procedures immediately after the procedure and at 30 days to determine whether there is an increase in new white lesions. Any other procedure other than the active collection of consent and data by the sponsor is standard of care for the treatment of carotid artery stenosis.
These patients will be monitored to document the incidence of post procedure DW-MRI lesions (relative to baseline).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients participating in this evaluation will be comprised of male and female symptomatic or asymptomatic patients requiring carotid revascularization.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcarotid Revascularization (TCAR)Also: Carotid Revascularization, Carotid Artery StentingCarotid revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent | Procedure or surgery | – |
Primary outcome
Incidence of Ipsilateral New White Lesions, by Patient
Time frame: Between 12-60 hours after procedure end time to 30 days post-procedure.
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.
Incidence of Ipsilateral Persistent Lesions, by Patient
Time frame: 30-days
Number of participants at 30 day post-procedure with persistent ipsilateral new white lesions post-procedure by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI).
5 secondary outcomes
All Stroke and Neurological Death
Time frame: 0 to 30 days
Volume of DW-MRI White Lesions
Time frame: 30-days
Location of DW-MRI Lesions
Time frame: 30-day
Stroke/Neurological Death in Patients Eligible and Ineligible for ROADSTER 2
Time frame: 0 to 30-day
Rate of Contralateral New White Lesions by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), by Patient
Time frame: 30-day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Results will be published following study end date.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Diseases and Carotid Atherosclerosis, run by Silk Road Medical at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Ipsilateral New White Lesions, by Patient (time frame: Between 12-60 hours after procedure end time to 30 days post-procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.