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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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 July 22, 2014