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Confidence: Carotid Stent Trial to Evaluate the Safety and Efficacy of the Roadsaver™ Stent Used in Conjunction with the Nanoparasol® Embolic Protection System for Patients at Increased Risk for Adverse Events from Carotid Endarterectomy

Short Description: The purpose of the trial is to evaluate the safety and efficacy of two systems, the MicroVention carotid stent system and the Nanoparasol embolic protection system when treating patients with carotid artery stenosis (this develops when the carotid artery becomes blocked or narrowed due to plaque build-up) who are also at risk of adverse events following carotid endarterectomy (which is a surgical procedure to remove the inner layer of artery walls plaque material, or blockage, in the lining of an artery constricted by the buildup of deposits). With the use of the MicroVention Carotid Stent system and the Nanoparasol embolic protection system, together these systems will increase blood to the brain while deceasing the narrowing of the artery preventing any future occurrence of a stroke. There will be 40 participating sites and up to 295 patients are expected to enroll in the study. Patient will be expected to complete follow up visits at 30 days, 6 months, 12, 24 and 36 months post procedure. Please contact Kate Dalton, MS, RD, CCRC at keb2114@columbia.edu if you have questions or would like to refer a patient.

Principal Investigator: Anthony Pucillo, MD

https://clinicaltrials.gov/ct2/show/NCT02657707?term=roadsaver&rank=2

Sponsor: Microvention-Terumo, Inc.

 
   
   
   
   
   
 

 

 

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