Multicenter randomized study evaluating the equivalence of carotid artery stenting using the Abbott Vascular Xact stent and Emboshield embolic protection system to standard endarterectomy in low-surgical-risk patients.
To evaluate the use of FDA-approved carotid stents and embolic protection systems CHOICD (Abbott), SAPPHIRE WW (Cordis), and CREATE PAS (ev3) in high-surgical-risk patients.
A non-randomized study to evaluate the safety and filter efficiency of the Lumen Biomedical FiberNet Embolic Protection System when used in conjunction with the FDA-approved Express SD stent system (Boston Scientific) for stenting of ostial atherosclerotic renal lesions.
A non-randomized study to assess the safety and efficacy of the RX Herculink Elite Renal Stent System (Abbott) for the treatment of suboptimal post-procedural percutaneous transluminam angioplasty (PTA) in atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
A non-randomized study to evaluate the safety and performance of the Expert stent (Abbott) in below-the-knee lesions as part of an overall treatment for infrapopliteal lesions in patients undergoing percutaneous intervention for critical limb ischemia.
VIVA II: SALVAGE
A non-randomized study to evaluate the safety and performance of Spectranetics LASER used with Viabahn Endoprosthesis with Heparin Bioactive Surface (Gore) for the treatment of superficial femoral artery in-stent restenosis.
A non-randomized study to evaluate the non-inferiority of the iCAST covered stent (Atrium Medical) for the treatment of iliac artery stenoses in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
A non-randomized study to evaluate the use of the PROTEGE EverFlex Nitinol stent system (ev3) in lesions of the superficial femoral artery and proximal popliteal artery.
A randomized study to compare the long-term safety and effectiveness of the Zilver PTX Drug-Eluting Vascular Stent (Cook Medical) to percutaneous transluminal angioplasty control in patients with de novo or restenotic lesions of the above-the-knee femoropopliteal artery that have not been previously stented.
A multi-center non-randomized study to assess the safety and efficacy of the new multi-polar left ventricular (LV) lead (St. Jude Medical) in the performance of cardiac resynchronization therapy defibrillator (CRT-D) in patients with impaired left ventricular systolic function and congestive heart failure
A multi-center randomized study to assess the safety and efficacy of the automated optimization of pacing timing using the QuickOpt (St. Jude Medical) algorithm as compared to other methods.