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

NCT ID: NCT00235157

Last Updated: 2008-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2005-07-31

Brief Summary

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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

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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.

Conditions

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Renal Artery Stenosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Sirolimus-eluting Palmaz Genesis peripheral stent

Group Type EXPERIMENTAL

Sirolimus-eluting Palmaz Genesis peripheral stent

Intervention Type DEVICE

treatment of renal artery stenosis with a renal stent

Interventions

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Sirolimus-eluting Palmaz Genesis peripheral stent

treatment of renal artery stenosis with a renal stent

Intervention Type DEVICE

Other Intervention Names

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Palmaz Genesis Stent

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cordis Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Cordis

Principal Investigators

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Markus Zähringer, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätskliniken Köln

Marc Sapoval, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Européen Georges Pompidou

Peter M Pattynama, MD

Role: PRINCIPAL_INVESTIGATOR

Erasmus MC Rotterdam

Locations

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Hopital Européen Georges Pompidou

Paris, , France

Site Status

Universitätskliniken Köln

Cologne, , Germany

Site Status

Erasmus MC Rotterdam

Rotterdam, , Netherlands

Site Status

Countries

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France Germany Netherlands

References

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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. doi: 10.1177/152660280701400405.

Reference Type RESULT
PMID: 17696619 (View on PubMed)

Other Identifiers

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EE01-01

Identifier Type: -

Identifier Source: org_study_id