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

University of Toledo Health Science Campus

Status and phase

Completed

Phase 2

Conditions

Renal Artery Stenosis

Treatments

Device: Renal Artery Stent with Protective Device/Drug

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00234585

xMUO-01

Details and patient eligibility

About

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.

Full 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?

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Any one or more of the following:

Meet Angiographic criteria plus