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Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions

NCT00081731 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 947

Last updated 2015-10-05

Study results available
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Summary

This study will compare medical therapy plus stenting of hemodynamically significant renal artery stenoses versus medical therapy alone in patients with systolic hypertension and renal artery stenosis.

Conditions

Interventions

DRUG

Atacand/HCT, Caduet

Atacand/HCT and caduet or optimal medical therapy for hypertension

PROCEDURE

GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting)

Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device

Sponsors & Collaborators

Principal Investigators

  • David Cohen, MD · Mid-America Heart Institute, St. Luke's Hospital, Kansas City, MO

  • Christopher J. Cooper, MD · University of Toledo

  • Donald Cutlip, MD · Beth Israel Deaconess Medcial Center

  • Alan Matsumoto, MD · University of Virginia School of Medicine

  • Michael Steffes, MD · University of Minnesota

  • Timothy P Murphy, MD · Rhode Island Hospital

  • Scott D Solomon, MD · Brigham and Women's Hospital

  • Lance D Dworkin, MD · Rhode Island Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00081731 on ClinicalTrials.gov