Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study (DW-MRI OUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03985774
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborators:
Complejo Hospitalario Toledo
University Ghent
Technische Universität München
Information provided by (Responsible Party):
Silk Road Medical

Brief Summary:
The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure.

Condition or disease Intervention/treatment
Carotid Stenosis Carotid Artery Diseases Carotid Atherosclerosis Carotid Artery Plaque Procedure: Carotid revascularization

Detailed Description:

The ENROUTE Transcarotid NPS has received CE Mark and is commercially available in the European Union. The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery stent approved for revascularization in patients with carotid disease in the context of this study.

This is a prospective, single-arm, multi-center clinical trial of the ENROUTE Transcarotid NPS in conjunction with all commercially approved carotid artery stents used for revascularization in patients with carotid disease.

The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure.

A patient is considered enrolled after:

  1. meeting all inclusion and none of the exclusion criteria,
  2. the transcarotid arterial sheath has entered into the patient's vasculature. Insertion of the venous sheath does not qualify a patient as enrolled.

Patients who are screened but do not meet all study criteria are considered screen failures and may not be enrolled. Patients in whom an arterial sheath is placed but who do not meet all study entry criteria are considered enrolled.

The Investigator is responsible for maintaining any information pertaining to the Ethics Committee review and approval as required by local law.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study
Actual Study Start Date : February 26, 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Group/Cohort Intervention/treatment
Patients requiring carotid revascularization
Symptomatic and asymptomatic patients, male of female that require carotid revascularization
Procedure: Carotid revascularization
The ENROUTE Transcarotid Neuroprotection System has received CE Mark and is commercially available in the European Union. The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery stent approved for revascularization in patients with carotid disease
Other Names:
  • Transcarotid Revascularization (TCAR)
  • Carotid Artery Stenting




Primary Outcome Measures :
  1. New White Lesions [ Time Frame: 30 days ]
    Incidence of new white lesions by DW-MRI post procedure.


Secondary Outcome Measures :
  1. Periprocedural SAEs [ Time Frame: 30 days ]
    All stroke

  2. Periprocedural SAEs [ Time Frame: 30 days ]
    All death

  3. post-procedure filter debris [ Time Frame: 30 days ]
    filter debris morphology

  4. DW-MRI Lesions [ Time Frame: 30 days ]
    Location of DW-MRI lesions

  5. DW-MRI Lesions [ Time Frame: 30 days ]
    Volume of DW-MRI lesions



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.


Layout table for eligibility information
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 enrolled into this study will be comprised of male and female symptomatic patients requiring carotid revascularization.
Criteria

Inclusion Criteria:

  • Patient is symptomatic and has a history of stroke (minor or non-disabling), TIA and/or amaurosis fugax within 60 days of the procedure.
  • Target vessel must meet diameter requirements for stent (refer to selected 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.

Exclusion Criteria:

  • 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.
  • Patient has an evolving stroke.
  • Patient has a history of spontaneous intracranial hemorrhage within the past 12 months.
  • Patient 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 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.
  • Patient has had a recent GI bleed that would interfere with antiplatelet therapy.
  • 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 with a history of major stroke (CVA) with major neurological deficit likely to confound study endpoints within 1 month of index procedure.
  • Patient has an intracranial tumor.
  • Patient is actively participating in another 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.
  • Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery.
  • Confirmed and uncorrected cardiac sources of emboli.
  • Patient has a prosthetic heart valve
  • Ostium of Common Carotid Artery (CCA) requires revascularization.
  • Presence of extensive or diffuse atherosclerotic disease involving the proximal common carotid artery that would preclude the safe introduction of the study device.
  • The patient has less than 5cm between the clavicle and bifurcation, as assessed by duplex Doppler ultrasound.
  • Bilateral carotid stenosis if intervention is planned within 37 days of the index procedure.
  • 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) that is not associated with an ulcerated target lesion.
  • Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis 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 had a previous intervention in the ipsilateral proximal CCA.
  • Patient is otherwise unsuitable for intervention in the opinion of the investigator

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): NCT03985774


Contacts
Layout table for location contacts
Contact: Richard Ruedy 408-585-2112 ric@silkroadmed.com

Locations
Layout table for location information
Belgium
Universitair Ziekenhuis Gent Completed
Gent, Belgium
Germany
Technischen Universitat Munchen Recruiting
Munich, Germany
Contact: Markus Zendler         
Principal Investigator: Hans-Henning Eckstein, MD         
Spain
Complejo Hospitalario de Toledo Completed
Toledo, Spain
Sponsors and Collaborators
Silk Road Medical
Complejo Hospitalario Toledo
University Ghent
Technische Universität München

Layout table for additonal information
Responsible Party: Silk Road Medical
ClinicalTrials.gov Identifier: NCT03985774     History of Changes
Other Study ID Numbers: SRM-2014-03
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

Layout table for additional information
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.: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Atherosclerosis
Carotid Stenosis
Carotid Artery Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases