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)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Renal Artery Stenosis
- Sponsor
- University of Toledo Health Science Campus
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Adverse Events
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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?
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Adverse Events
Glomerular Filtration Rate