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Peripheral

 

Flextstent: Evaluation of the Flex Stent FemPop Self-expanding Stent System in SFAs.

Short Description: This study will examine whether the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease. Specifically, it will examine whether the FlexStent® meets or exceeds the proposed safety and efficacy performance goals established for Femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Safety will be assessed by monitoring adverse events. Subject needs to have a single de-novo lesion in the femoropopliteal artery with >70% stenosis

Principal Investigator: William A. Gray, MD

http://www.clinicaltrials.gov/ct2/show/NCT01355406?term=flexstent&rank=1

 

 

GORE Freedom: Evaluation of the GORE® Flow Reversal System and the GORE® Embolic Filter when used for embolic protection during carotid artery stenting

Short Description: The purpose of this study is to obtain more information about the GORE® Flow Reversal System and the GORE® Embolic Filter when used with an FDA-approved carotid stent in patients who have blockages in their carotid (neck) arteries. The carotid stenting procedure will be done according to standard of care. The GORE® Flow Reversal System and the GORE® Embolic Filter are devices designed to protect the brain from particles (emboli) that may break off when the narrowing or blockage (stenosis) is cleared. It provides protection during carotid artery angioplasty and stenting, which is the procedure that clears the blockage in the artery. Both devices are approved by the U.S. Food and Drug Administration for use in these procedures. During the procedure, the study doctor will decide which protection device, the GORE® Flow Reversal System or the GORE® Embolic Filter is best suited for the blockage based on the patient's anatomy.

Principal Investigator: William A. Gray, MD

http://www.clinicaltrials.gov/ct2/show/NCT01343667?term=Gore+freedom&rank=1

 

 

Roadster: Investigation of flow altered, short transcervical carotid artery stenting in patients with significant carotid artery disease with filter

Short Description: This study will evaluate the safety and effectiveness of the MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) in providing cerebral embolic protection during carotid artery stenting. When the carotid artery has a significant narrowing it can cause a stroke or short-lived blindness. It has been shown that widening the narrowed portion of the artery by using a stent may reduce the risk of a stroke. During the stent placement procedure, debris can break off from the narrowed area of the artery. The MICHI NPS+f is designed to shunt material/debris away from the brain in order to stop this material from blocking blood flow to the arteries beyond the narrowing and thus being harmful to the brain.

Principal Investigator: Philip Meyers, MD

http://www.clinicaltrials.gov/ct2/show/NCT01685567?term=silk+road&rank=2

 

 

 

 

 
   
   
   
   
   
 

 

 

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