NCT00234585

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: University of Toledo Health Science Campus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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?

Conditions

• Renal Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Renal Artery Stent with Protective Device/Drug

Timeline

• Start date: 2002-08-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2005-10-07
• Last updated: 2014-12-10

Locations

1 site across 1 country: United States