Prospective Randomized Study Comparing Renal Artery Stenting (RESIST)With/Without Distal Protection

Renal Artery Stenosis

This study is designed to demonstrate the safety and efficacy of using a protective device/drug to prevent renal injury during renal artery stenting and to assess whether the preventative effects are measurable and if there is a differential treatment effect for either device alone or in combination.

This study is designed to demonstrate the safety and efficacy of using protective device/drug to prevent renal injury during renal artery stenting (RAS) and to assess whether the preventative effects are measurable, and if there is a differential treatment effect for either device alone or in combination. Specific goals of the study include: * To establish device and drug safety * To identify appropriate markers for renal injury * To measure effectiveness of drug and device * To enable the design of FDA efficacy trials for renal artery stenting inclusive of device and or drug The study will address the four following hypotheses: * AngioGuard™ distal protection device provides significant protection from atheroembolization during RAS procedures as measured by affected kidney GFR at 1 month after the procedure. * Abciximab (ReoPro) offers protection against platelet aggregation and embolization as measured by affected kidney GFR at 1 month after the procedure. * AngioGuard™ and Abciximab are safe, alone and in combination. * Is there an interaction effect between AngioGuard™ and ReoPro for efficacy and safety?

United States