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

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ClinicalTrials.gov Identifier: NCT03982420
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
Indiana University
University of Navarra
Stanford University
Information provided by (Responsible Party):
Silk Road Medical

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.

Condition or disease Intervention/treatment
Carotid Artery Diseases Carotid Atherosclerosis Carotid Stenosis Carotid Artery Plaque Carotid Disease Procedure: Transcarotid Revascularization (TCAR)

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).


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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Intervention Details:
  • Procedure: Transcarotid Revascularization (TCAR)
    Carotid revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent
    Other Name: Carotid Revascularization, Carotid Artery Stenting


Primary Outcome Measures :
  1. Incidence of ipsilateral new white lesions [ Time Frame: 30 days ]
    Incidence of ipsilateral new white lesions from baseline (pre-procedure) by DW-MRI to 30 days post procedure


Secondary Outcome Measures :
  1. Incidence of Periprocedural SAEs [ Time Frame: 30 days ]
    All stroke, Neurological Death, Stroke/Neurological Death in patients eligible for ROADSTER 2, Stroke/Neurological Death in patients ineligible for ROADSTER 2

  2. Rate of contralateral new white lesions by DW-MRI [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria

  • 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.
  • 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982420


Contacts
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Contact: Exec. VP, Clinical Affairs 408-585-2112 ric@silkroadmed.com

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06519
Contact: Research Coordinator, RN    203-785-3490    lindsey.fraczkiewicz@yale.edu   
Principal Investigator: Charles Matouk, MD         
United States, Indiana
Indiana University, Vascular Surgery Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Research Nurse    317-962-0287    jswklein@iupui.edu   
Principal Investigator: Raghu Motaganahalli, MD         
United States, New York
Stony Brook University Medical Center Not yet recruiting
Stony Brook, New York, United States, 11794
Contact: Research Coordinator    631-578-0250    Giuseppe.Caso@stonybrookmedicine.edu   
Principal Investigator: Angela Kokkosis, MD         
Spain
Clinica Universidad de Navarra Recruiting
Madrid, Spain, 28022
Contact: Research Coordinator    34690776518    lrubio@unav.es   
Principal Investigator: Jose Ignacio Leal Lorenzo, MD         
Sponsors and Collaborators
Silk Road Medical
Indiana University
University of Navarra
Stanford University

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Responsible Party: Silk Road Medical
ClinicalTrials.gov Identifier: NCT03982420     History of Changes
Other Study ID Numbers: SRM-2018-01
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Results will be published following study end date.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Arterial Occlusive Diseases
Atherosclerosis
Arteriosclerosis
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases