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

Renal Artery Stenosis Clinical Trial

Official title: 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)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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? ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Artery Obstruction
• Renal Artery Stenosis

• NCT number: NCT00234585
• Study type: Interventional
• Source: University of Toledo Health Science Campus
• Status: Completed
• Phase: Phase 2
• Start date: August 2002
• Completion date: June 2007