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

A Prospective Randomized Multicenter Study Comparing the Safety and Efficacy of Renal Artery Stenting With/Without Distal Protection Device (AngioGuard) and With/Without the Use of a Platelet Aggregator Inhibitor (Abciximab-Reopro) (RESIST)

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?

Inclusion Criteria:

Any one or more of the following:

Meet Angiographic criteria plus

• Systemic hypertension at baseline, or a history of hypertension
• Congestive heart failure at baseline, or a history of CHF
• Renal insufficiency at baseline, or a history of renal insufficiency
• Angina, or a history of angina

Exclusion Criteria:

• Less than 18 years old
• Contraindications to device/drug