Clinical trial NCT03985774: The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study
Official title: The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Stenosis
Carotid Artery Diseases
Carotid Atherosclerosis
Carotid Artery Plaque
Lead sponsor: Silk Road Medical
Sponsor class: INDUSTRY
Collaborators: name: Complejo Hospitalario Toledo
name: University Ghent
name: Technical University of Munich
First posted: 2019-06-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled into this study will be comprised of male and female symptomatic patients requiring carotid revascularization.

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.

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 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

Primary outcomes:
measure: New White Lesions
timeFrame: 30 days
Secondary outcomes:
measure: Periprocedural SAEs
timeFrame: 30 days
measure: Periprocedural SAEs
timeFrame: 30 days
measure: post-procedure filter debris
timeFrame: 30 days
measure: DW-MRI Lesions
timeFrame: 30 days
measure: DW-MRI Lesions
timeFrame: 30 days
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Munich
country: Germany
facility: Technischen Universitat Munchen
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo
Study officials:
References: