A Comparison of Coated and Uncoated Stents in Renal Artery Treatment. - Full Text View

Sponsored by:	Cordis Corporation
Information provided by:	Cordis Corporation
ClinicalTrials.gov Identifier:	NCT00235157

Purpose

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.

Condition	Intervention	Phase
Renal Artery Stenosis	Device: Sirolimus-eluting Palmaz Genesis peripheral stent	Phase II

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	105
Study Start Date:	November 2001
Study Completion Date:	July 2005
Primary Completion Date:	November 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Sirolimus-eluting Palmaz Genesis peripheral stent	Device: Sirolimus-eluting Palmaz Genesis peripheral stent treatment of renal artery stenosis with a renal stent

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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235157

Locations

France
Hopital Européen Georges Pompidou
Paris, France, 75 015
Germany
Universitätskliniken Köln
Köln, Germany, 50931
Netherlands
Erasmus MC Rotterdam
Rotterdam, Netherlands, 3000 CA

Sponsors and Collaborators

Cordis Corporation

Investigators

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

More Information

Publications of Results:

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.

Responsible Party:	Cordis ( Dr. Hans-Peter Stoll, Director Clinical Affairs )
Study ID Numbers:	EE01-01
Study First Received:	October 6, 2005
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00235157
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Sirolimus
Arterial Occlusive Diseases
Renal artery stenosis
Urologic Diseases
Clotrimazole
Miconazole

Tioconazole
Vascular Diseases
Constriction, Pathologic
Kidney Diseases
Renal Artery Obstruction

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents
Therapeutic Uses

Physiological Effects of Drugs
Cardiovascular Diseases
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009