Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234585
Status:
COMPLETED
Last Update Posted:
2014-12-10
First Post:
2005-10-05
Brief Title:
Prospective Randomized Study Comparing Renal Artery Stenting RESISTWithWithout Distal Protection
Sponsor:
University of Toledo Health Science Campus
Organization:
University of Toledo
Study Overview
Official Title:
A Prospective Randomized Multicenter Study Comparing the Safety and Efficacy of Renal Artery Stenting WithWithout Distal Protection Device AngioGuard and WithWithout the Use of a Platelet Aggregator Inhibitor Abciximab-Reopro RESIST
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to demonstrate the safety and efficacy of using a protective devicedrug 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 devicedrug 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None