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

This study has been completed.

Sponsor:

Information provided by:

Cordis Corporation

ClinicalTrials.gov Identifier:

NCT00235157

First received: October 6, 2005

Last updated: August 5, 2008

Last verified: August 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

October 6, 2005

Last Updated Date

August 5, 2008

Start Date ^ICMJE

November 2001

Primary Completion Date

November 2002 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

assessment of the angiographical in-stent minimal lumen diameter [ Time Frame: 6-months follow up ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

The primary endpoint is the angiographical determination of in-stent percent diameter stenosis (%DS) at 6 months follow up comparing the uncoated and the coated version.

Change History

Complete list of historical versions of study NCT00235157 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

clinical primary patency [ Time Frame: discharge, 1, 6 and 12 months post-procedure ] [ Designated as safety issue: Yes ]
procedural success [ Time Frame: post-procedure ] [ Designated as safety issue: Yes ]
worsening renal function [ Time Frame: 30 days, 6 months, 12 months ] [ Designated as safety issue: Yes ]
change in blood pressure measurement [ Time Frame: 30 days, 6 months, 12 months ] [ Designated as safety issue: Yes ]
significant embolic events causing end-organ damage [ Time Frame: 30 days, 6 months, and 12 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Renal Artery Stenosis

Intervention ^ICMJE

Device: Sirolimus-eluting Palmaz Genesis peripheral stent

treatment of renal artery stenosis with a renal stent

Other Name: Palmaz Genesis Stent

Study Arm (s)

Experimental: 1

Sirolimus-eluting Palmaz Genesis peripheral stent

Intervention: Device: Sirolimus-eluting Palmaz Genesis peripheral stent

Publications *

Zahringer M, Sapoval M, Pattynama PM, Rabbia C, Vignali C, Maleux G, Boyer L, Szczerbo-Trojanowska M, Jaschke W, Hafsahl G, Downes M, Beregi JP, Veeger NJ, Stoll HP, Talen A. Sirolimus-eluting versus bare-metal low-profile stent for renal artery treatment (GREAT Trial): angiographic follow-up after 6 months and clinical outcome up to 2 years. J Endovasc Ther. 2007 Aug;14(4):460-8.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

105

Completion Date

July 2005

Primary Completion Date

November 2002 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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.
The reference vessel renal artery must be >= 4mm and <= 8 mm by visual estimate.
The patient must have a baseline serum creatinine of <= 5.0 mg/dl.

Exclusion Criteria:

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

Gender

Both

Ages

30 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France, Germany, Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00235157

Other Study ID Numbers ^ICMJE

EE01-01

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Hans-Peter Stoll, Director Clinical Affairs, Cordis

Study Sponsor ^ICMJE

Cordis Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Markus Zähringer, MD	Universitätskliniken Köln
Principal Investigator:	Marc Sapoval, MD	Hopital Européen Georges Pompidou
Principal Investigator:	Peter M Pattynama, MD	Erasmus MC Rotterdam

Information Provided By

Cordis Corporation

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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