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

Cordis

Status and phase: Completed; Phase 2

Conditions: Renal Artery Stenosis

Treatments: Device: Sirolimus-eluting Palmaz Genesis peripheral stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00235157

EE01-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

1

Experimental group

Description:

Sirolimus-eluting Palmaz Genesis peripheral stent

Treatment:

Device: Sirolimus-eluting Palmaz Genesis peripheral stent