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

Cordis US Corp.105 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Renal Artery Stenosis

Interventions

Sirolimus-eluting Palmaz Genesis peripheral stentDEVICE

treatment of renal artery stenosis with a renal stent

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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.

Locations (3)

Hopital Européen Georges Pompidou

Paris, France

Universitätskliniken Köln

Cologne, Germany

Erasmus MC Rotterdam

Rotterdam, Netherlands

Outcomes

Primary Outcomes

assessment of the angiographical in-stent minimal lumen diameter

Time frame: 6-months follow up

Secondary Outcomes

clinical primary patency

Time frame: discharge, 1, 6 and 12 months post-procedure

procedural success

Time frame: post-procedure

worsening renal function

Time frame: 30 days, 6 months, 12 months

change in blood pressure measurement

Time frame: 30 days, 6 months, 12 months

significant embolic events causing end-organ damage

Time frame: 30 days, 6 months, and 12 months

Data from ClinicalTrials.gov

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