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A Comparison of Coated and Uncoated Stents in Renal Artery Treatment.

NCT00235157 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2008-08-06

No results posted yet for this study

Summary

The primary objective of this study is to compare the safety and performance of the Palmaz Genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of renal artery stenosis, measured at 6 months follow up via angiography.

Conditions

  • Renal Artery Stenosis

Interventions

DEVICE

Sirolimus-eluting Palmaz Genesis peripheral stent

treatment of renal artery stenosis with a renal stent

Sponsors & Collaborators

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • Markus Zähringer, MD · Universitätskliniken Köln

  • Marc Sapoval, MD · Hopital Européen Georges Pompidou

  • Peter M Pattynama, MD · Erasmus MC Rotterdam

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2002-11-30
Completion
2005-07-31

Countries

  • France
  • Germany
  • Netherlands

Study Locations

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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 NCT00235157 on ClinicalTrials.gov