Prospective Randomized Study Comparing Renal Artery Stenting (RESIST)With/Without Distal Protection

This study has been completed.

Sponsor:

Collaborators:

Centocor, Inc.

Johnson & Johnson

Information provided by:

University of Toledo Health Science Campus

ClinicalTrials.gov Identifier:

NCT00234585

First received: October 5, 2005

Last updated: February 4, 2009

Last verified: February 2009

History of Changes

Purpose

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.

Condition	Intervention	Phase
Renal Artery Stenosis	Device: Renal Artery Stent with Protective Device/Drug	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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)

Further study details as provided by University of Toledo Health Science Campus:

Primary Outcome Measures:

Glomerular Filtration Rate
Adverse Events

Estimated Enrollment:	100
Study Start Date:	August 2002
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

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?

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234585

Locations

United States, Ohio
Medical University of Ohio
Toledo, Ohio, United States, 43614

Sponsors and Collaborators

University of Toledo Health Science Campus

Centocor, Inc.

Johnson & Johnson

Investigators

Principal Investigator:

Christopher Cooper, M.D.

Medical University of Ohio

More Information

No publications provided by University of Toledo Health Science Campus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. 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.

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.

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. Epub 2008 May 19.

Responsible Party:	Christopher Cooper, MD, University of Toledo HSC
ClinicalTrials.gov Identifier:	NCT00234585 History of Changes
Other Study ID Numbers:	MUO-01
Study First Received:	October 5, 2005
Last Updated:	February 4, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Renal Artery Obstruction
Kidney Diseases
Urologic Diseases

Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013

To Top