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

Renal Artery Stenosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234585
• Other study ID #: xMUO-01
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2005
• Last updated: December 9, 2014
• Start date: August 2002
• Est. completion date: June 2007

Study information

• Verified date: December 2014
• Source: University of Toledo Health Science Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Renal Artery Obstruction
• Renal Artery Stenosis

Intervention

Device:
• Renal Artery Stent with Protective Device/Drug

Locations

Country	Name	City	State
United States	Medical University of Ohio	Toledo	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
University of Toledo Health Science Campus	Centocor, Inc., Johnson & Johnson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular Filtration Rate
Primary	Adverse Events