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

NCT03985774 | Completed FDA Device

• 1 other identifier: SRM-2014-03
• Study Type: observational
• Target: 31
• Locations: 3 countries
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• New White Lesions

  Incidence of new white lesions by DW-MRI post procedure.

  30 days

Secondary Outcomes (5)

• Periprocedural SAEs

  30 days

• Periprocedural SAEs

  30 days

• post-procedure filter debris

  30 days

• DW-MRI Lesions

  30 days

• DW-MRI Lesions

  30 days

Study Arms (1)

Patients requiring carotid revascularization

Symptomatic patients, male or female, with atherosclerotic extracranial internal carotid stenosis (ICA) with or without involvement of the contiguous common artery (CCA), that require carotid revascularization.

Procedure: Transcarotid revascularization

Interventions

Transcarotid revascularization PROCEDURE

The ENROUTE Transcarotid Neuroprotection System (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 The ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis

Also known as: Transcarotid Revascularization (TCAR), Carotid Artery Stenting

Patients requiring carotid revascularization

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 enrolled into this study will be comprised of male and female symptomatic patients requiring carotid revascularization.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Silk Road Medical: lead
• Complejo Hospitalario Toledo: collaborator
• University Ghent: collaborator
• Technical University of Munich: collaborator

Study Sites (3)

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

Technischen Universitat Munchen

Munich, Germany

Location

Complejo Hospitalario de Toledo

Toledo, Spain

Location

MeSH Terms

Conditions

Carotid Stenosis; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 14, 2019
• Study Start: February 26, 2015
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

BE (1); DE (1); ES (1)