Prospective Randomized Study Comparing Renal Artery Stenting (RESIST)With/Without Distal Protection
NCT ID: NCT00234585
Last Updated: 2014-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2002-08-31
2007-06-30
Brief Summary
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Detailed Description
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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?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Renal Artery Stent with Protective Device/Drug
Eligibility Criteria
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Inclusion Criteria
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
* Contraindications to device/drug
18 Years
ALL
No
Sponsors
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Centocor, Inc.
INDUSTRY
Johnson & Johnson
INDUSTRY
University of Toledo Health Science Campus
OTHER
Responsible Party
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Principal Investigators
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Christopher Cooper, M.D.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Ohio
Locations
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Medical University of Ohio
Toledo, Ohio, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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xMUO-01
Identifier Type: -
Identifier Source: org_study_id