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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. The FlexStent Femoropopliteal Self-Expanding Stent system may provide a great range of motions for a highly flexible femoral artery while adequately supporting the vessel. The potential benefits may include improved blood flow and relief of leg symptoms (usually pain) which may facilitate an improvement in general fitness and well-being. 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

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

 

 

DANCE: Delivery of Dexamethasone to the Adventitia to enhance clinical efficacy after Femoropopliteal Revascularization

Short Description: Single-arm trial to assess the safety and effectiveness of Mercator Micro-Infusion Catheter adventitial deposition of dexamethasone in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the superficial femoral and/or popliteal arteries. 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

http://clinicaltrials.gov/ct2/show/NCT01507558?term=dexamethasone+and+SFA&rank=1

 

 

LIBERTY 360: Prospective, Observational, Multi-Center Clinical Study to Evaluate Acute and Long Term Clinical and Economic Outcomes of Endovascular Device Intervention in Patients with Distal Outflow Peripheral Arterial Disease (PAD)

Short Description: This prospective, multi-center clinical study is designed to collect observational clinical data for subjects with distal outflow Peripheral Arterial Disease (PAD) who are suitable for endovascular device intervention. Only endovascular devices cleared or approved for commercial use by the Food and Drug Administration (FDA) can be used in this study per their specific indications for use (no investigational devices are permitted to be used). The study objectives are: 1. Evaluate procedural and long-term clinical and economic outcomes for subjects undergoing peripheral endovascular device intervention of distal outflow PAD that includes a target lesion located within 10 cm above the medial epicondyle to the digital arteries. 2. Create a universal classification schema to describe the distribution and plaque burden, including calcium, for disease in distal outflow PAD. Develop the LIBERTY Plaque Burden Score to provide additional guidance for future interventions and to predict clinical outcomes. Please contact Kate Dalton, MS, RD, CCRC at keb2114@columbia.edu if you have questions or would like to refer a patient.

Principal Investigator: William A. Gray, MD

http://clinicaltrials.gov/ct2/show/NCT01855412?term=liberty+360&rank=1

 

 

 

Endomax: Endovascular Interventions with Angiomax

Short Description: This is an international, multicenter, double-blind, randomized, controlled trial of bivalirudin versus unfractionated-heparin (UFH) in subjects undergoing PEI. Subjects will be randomized (1:1) to receive either bivalirudin or UHF. Both are used as standard of care for endovascular procedures, but Bivalirudin is not approved specifically for this use. The primary objective of the study is to demonstrate that anticoagulation with bivalirudin results in fewer major bleeding complications compared with UFH in subjects undergoing peripheral endovascular interventions (PEI). Please contact Kate Dalton, MS, RD, CCRC at keb2114@columbia.edu if you have questions or would like to refer a patient.

http://clinicaltrials.gov/ct2/show/NCT01913483?term=endomax&rank=1

 

SCAFFOLD: GORE® Carotid Stent Clinical Study for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy.

Short Desciption: The purpose of this study is to compare outcomes in patients who receive to the GORE Carotid Stent as compared to historical CEA outcomes in the treatment of carotid artery stenosis in patients at increased risk for surgery. Up to 312 subjects Patients who are at least 18 years of age with anatomic or medical comorbities that place them at high perioperative risk for CEA and who have either de novo atherosclerotic or postendarterectomy restenotic lesions in the internal carotid arteries at the carotid bifurcation, with (stroke, TIA, TMB within 180 days of procedure), or ≥80% (by angiography) stenosis if asymptomatic. Subjects will be evaluated through hospital discharge and return for follow-up visits at 30-days, 6 months, and 1, 2 and 3 years post procedure. Please contact Kate Dalton, MS, RD, CCRC at keb2114@columbia.edu if you have questions or would like to refer a patient.

 

 

 
   
   
   
   
 

 

 

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