The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation (NCT03982420) | Clinical Trial Compass
CompletedNot Applicable
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation
United States55 participantsStarted 2019-06-27
Plain-language summary
The goal of this evaluation is to document the incidence of post procedure DW-MRI lesions (relative to baseline) in patients treated with the transcarotid artery revascularization (TCAR) procedure.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Stenosis must be \>50% as determined by ultrasound or angiogram1 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.
* Stenosis must be \>80% as determined by ultrasound or angiogram without any neurological symptoms within the prior 180 days.
* Target vessel must meet diameter requirements for stent (refer to 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.
* Patient must have a life expectancy ≥ 3 years at the time of the index procedure without contingencies related to other medical, surgical or endovascular intervention.
* Patient meets at least one of the surgical high-risk criteria listed in CMS National Coverage Determination (NCD) for Percutaneous Transluminal Angioplasty (20.7)
Exclusion Criteria
* Alternative source of cerebral embolus
* 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 cardiac sources of emboli. e.g. left ventricular aneurysm, intracardiac…
What they're measuring
1
Incidence of Ipsilateral New White Lesions, by Patient
Timeframe: Between 12-60 hours after procedure end time to 30 days post-procedure.
2
Incidence of Ipsilateral Persistent Lesions, by Patient