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

August 5, 2008 updated by: Cordis Corporation

Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Multi-center, prospective, controlled, non-randomized investigational feasibility study. One hundred (100) patients with de novo or restenotic renal artery lesions consisting of >= 50% stenosis and reference vessel of >= 4.0 to <= 8.0 mm in diameter will be sequentially included, 50 without sirolimus coating, followed by 50 with sirolimus coating Palmaz GenesisTM. Patients will be followed for 24 months post-procedure, with all patients having clinical assessments at discharge, 1,6, 12 and 24 months. This study will be conducted at twelve investigational sites.

It is anticipated that the total length of time required to complete the study will be 46 months.

Study Type

Interventional

Enrollment (Actual)

105

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

  • France
      • Paris, France, 75 015
        • Hôpital Europeén Georges Pompidou
  • Germany
      • Köln, Germany, 50931
        • Universitätskliniken Köln
  • Netherlands
      • Rotterdam, Netherlands, 3000 CA
        • Erasmus MC Rotterdam

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

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Clinical indication for renal artery revascularization of atherosclerotic renal artery stenosis >=50% as measured by operator or estimated original vessel diameter, based on healthy vessel segment and contralateral side.
  2. The reference vessel renal artery must be >= 4mm and <= 8 mm by visual estimate.
  3. The patient must have a baseline serum creatinine of <= 5.0 mg/dl.

Exclusion Criteria:

  1. Total occlusion of the renal artery.
  2. Lesions which would require more than 2 stents.
  3. Lesions which are in arteries to transplanted or bypassed kidneys.
  4. Abdominal aortic aneurysm > 4.0 cm in diameter.
  5. Patients with ASA classification >=4.

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Sirolimus-eluting Palmaz Genesis peripheral stent
Device: Sirolimus-eluting Palmaz Genesis peripheral stent
treatment of renal artery stenosis with a renal stent
Other Names:
  • Palmaz Genesis Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
assessment of the angiographical in-stent minimal lumen diameter
Time Frame: 6-months follow up
6-months follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical primary patency
Time Frame: discharge, 1, 6 and 12 months post-procedure
discharge, 1, 6 and 12 months post-procedure
procedural success
Time Frame: post-procedure
post-procedure
worsening renal function
Time Frame: 30 days, 6 months, 12 months
30 days, 6 months, 12 months
change in blood pressure measurement
Time Frame: 30 days, 6 months, 12 months
30 days, 6 months, 12 months
significant embolic events causing end-organ damage
Time Frame: 30 days, 6 months, and 12 months
30 days, 6 months, and 12 months

Collaborators and Investigators

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

Sponsor

Cordis Corporation

Investigators

  • Principal Investigator: Markus Zähringer, MD, Universitätskliniken Köln
  • Principal Investigator: Marc Sapoval, MD, Hôpital Europeén Georges Pompidou
  • Principal Investigator: Peter M Pattynama, MD, Erasmus MC Rotterdam

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

November 1, 2001

Primary Completion (ACTUAL)

November 1, 2002

Study Completion (ACTUAL)

July 1, 2005

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (ESTIMATE)

October 10, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2008

Last Update Submitted That Met QC Criteria

August 5, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EE01-01

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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