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

Phase 2

Completed

• Conditions: Renal Artery Stenosis

• Registration Number: NCT00234585
• Lead Sponsor: University of Toledo Health Science Campus

Brief 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?

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2005-10-05
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-07
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adverse Events
Glomerular Filtration Rate

Trial Locations

Locations (1)

Medical University of Ohio; 🇺🇸 Toledo, Ohio, United States