Prospective Randomized Study Comparing Renal Artery Stenting (RESIST)With/Without Distal Protection
Primary Purpose
Renal Artery Stenosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Renal Artery Stent with Protective Device/Drug
Sponsored by
About this trial
This is an interventional treatment trial for Renal Artery Stenosis
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
Sites / Locations
- Medical University of Ohio
Outcomes
Primary Outcome Measures
Glomerular Filtration Rate
Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT00234585
First Posted
October 5, 2005
Last Updated
December 9, 2014
Sponsor
University of Toledo Health Science Campus
Collaborators
Centocor, Inc., Johnson & Johnson
1. Study Identification
Unique Protocol Identification Number
NCT00234585
Brief Title
Prospective Randomized Study Comparing Renal Artery Stenting (RESIST)With/Without Distal Protection
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 Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Toledo Health Science Campus
Collaborators
Centocor, Inc., Johnson & Johnson
4. Oversight
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Artery Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Renal Artery Stent with Protective Device/Drug
Primary Outcome Measure Information:
Title
Glomerular Filtration Rate
Title
Adverse Events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Cooper, M.D.
Organizational Affiliation
Medical University of Ohio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35224730
Citation
Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
Results Reference
derived
PubMed Identifier
21908683
Citation
Yu H, Zhang D, Haller S, Kanjwal K, Colyer W, Brewster P, Steffes M, Shapiro JI, Cooper CJ. Determinants of renal function in patients with renal artery stenosis. Vasc Med. 2011 Oct;16(5):331-8. doi: 10.1177/1358863X11419998. Epub 2011 Sep 9.
Results Reference
derived
PubMed Identifier
20823380
Citation
Tian J, Haller S, Periyasamy S, Brewster P, Zhang H, Adlakha S, Fedorova OV, Xie ZJ, Bagrov AY, Shapiro JI, Cooper CJ. Renal ischemia regulates marinobufagenin release in humans. Hypertension. 2010 Nov;56(5):914-9. doi: 10.1161/HYPERTENSIONAHA.110.155564. Epub 2010 Sep 7.
Results Reference
derived
PubMed Identifier
20209644
Citation
Kanjwal K, Cooper CJ, Virmani R, Haller S, Shapiro JI, Burket MW, Steffes M, Brewster P, Zhang H, Colyer WR Jr. Predictors of embolization during protected renal artery angioplasty and stenting: Role of antiplatelet therapy. Catheter Cardiovasc Interv. 2010 Jul 1;76(1):16-23. doi: 10.1002/ccd.22469.
Results Reference
derived
PubMed Identifier
19198007
Citation
Kanjwal K, Haller S, Steffes M, Virmani R, Shapiro JI, Burket MW, Cooper CJ, Colyer WR Jr. Complete versus partial distal embolic protection during renal artery stenting. Catheter Cardiovasc Interv. 2009 May 1;73(6):725-30. doi: 10.1002/ccd.21932. Erratum In: Catheter Cardiovasc Interv. 2009 Aug 1;74(2):375.
Results Reference
derived
PubMed Identifier
18490527
Citation
Cooper CJ, Haller ST, Colyer W, Steffes M, Burket MW, Thomas WJ, Safian R, Reddy B, Brewster P, Ankenbrandt MA, Virmani R, Dippel E, Rocha-Singh K, Murphy TP, Kennedy DJ, Shapiro JI, D'Agostino RD, Pencina MJ, Khuder S. Embolic protection and platelet inhibition during renal artery stenting. Circulation. 2008 May 27;117(21):2752-60. doi: 10.1161/CIRCULATIONAHA.107.730259. Epub 2008 May 19.
Results Reference
derived
Learn more about this trial
Prospective Randomized Study Comparing Renal Artery Stenting (RESIST)With/Without Distal Protection
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