A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation

About this trial

The study is a prospective, non-randomized, single-arm, multi-center registry to confirm the safe delivery of the Carotid WALLSTENT Endoprosthesis when used with the ENROUTE® Transcarotid Neuroprotection System in the Chinese population

Eligibility criteria

Qualifiers

1. Patients must meet one of the following criteria regarding neurological symptom status and degree of stenosis: Symptomatic: Stenosis must be >50% as determined by an angiogram (CTA/MRA or catheter angiogram prior to the index procedure) 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.

Disqualifiers

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 any cardiac sources of emboli. (including but not limited to 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.

Trial design

Treatments tested in this trial

  • transcarotid artery revascularization

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators