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

Study Overview
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Brief Summary
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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
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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?

Official Title
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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)

Conditions
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Renal Artery Stenosis

Intervention / Treatment
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* Device: Renal Artery Stent with Protective Device/Drug


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Renal Artery Stent with Protective Device/Drug|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular Filtration Rate |  |  | 
| Adverse Events |  |  |