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The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study | Clinical Trials | Clareo Health

COMPLETED

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

NCT03985774•Silk Road Medical

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+15 more criteria

Locations (3)

Universitair Ziekenhuis Gent

Ghent, Belgium

Technischen Universitat Munchen

Munich, Germany

Complejo Hospitalario de Toledo

Toledo, Spain

Key Dates

Start Date

February 26, 2015

Primary Completion Date

March 25, 2021

Completion Date

March 25, 2021

Last Updated

April 19, 2021

Enrollment

ACTUAL participants

Conditions

Carotid StenosisCarotid Artery DiseasesCarotid AtherosclerosisCarotid Artery Plaque

Interventions

Transcarotid revascularization

PROCEDURE

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

NCT07322913

Carotid Artery DiseasesAortic Diseases+1 more

View study

RECRUITINGNA

Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis

NCT07412249

Carotid Stenosis

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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