Prospective Randomized Study Comparing Renal Artery Stenting (RESIST)With/Without Distal Protection
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|ClinicalTrials.gov Identifier: NCT00234585|
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : December 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Renal Artery Stenosis||Device: Renal Artery Stent with Protective Device/Drug||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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)|
|Study Start Date :||August 2002|
|Primary Completion Date :||June 2007|
|Study Completion Date :||June 2007|
- Glomerular Filtration Rate
- Adverse Events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234585
|United States, Ohio|
|Medical University of Ohio|
|Toledo, Ohio, United States, 43614|
|Principal Investigator:||Christopher Cooper, M.D.||Medical University of Ohio|