Prospective Randomized Study Comparing Renal Artery Stenting (RESIST)With/Without Distal Protection
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.
Renal Artery Stenosis
Device: Renal Artery Stent with Protective Device/Drug
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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)|
- Glomerular Filtration Rate
- Adverse Events
|Study Start Date:||August 2002|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
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?
|United States, Ohio|
|Medical University of Ohio|
|Toledo, Ohio, United States, 43614|
|Principal Investigator:||Christopher Cooper, M.D.||Medical University of Ohio|