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

December 9, 2014 updated by: University of Toledo Health Science Campus

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse Events
Glomerular Filtration Rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toledo Health Science Campus

Collaborators

Johnson & Johnson
Centocor, Inc.

Investigators

  • Principal Investigator: Christopher Cooper, M.D., Medical University of Ohio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

October 5, 2005

First Submitted That Met QC Criteria

October 5, 2005

First Posted (Estimate)

October 7, 2005

Study Record Updates

Last Update Posted (Estimate)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 9, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xMUO-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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