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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Adverse Events
Study 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?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported