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

Phase 2

Completed

• Conditions: Renal Artery Stenosis
• Interventions: Device: Sirolimus-eluting Palmaz Genesis peripheral stent

• Registration Number: NCT00235157
• Lead Sponsor: Cordis Corporation

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 Timeline

• Study Start: 2001-11
• Primary Completion: 2002-11
• Study Completion: 2005-07
• Study First Submitted: 2005-10-06
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-10
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-05
• Last Update Posted: 2008-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Sirolimus-eluting Palmaz Genesis peripheral stent	Sirolimus-eluting Palmaz Genesis peripheral stent

Primary Outcome Measures

Name	Time	Method
assessment of the angiographical in-stent minimal lumen diameter	6-months follow up

Secondary Outcome Measures

Name	Time	Method
clinical primary patency	discharge, 1, 6 and 12 months post-procedure
procedural success	post-procedure
worsening renal function	30 days, 6 months, 12 months
change in blood pressure measurement	30 days, 6 months, 12 months
significant embolic events causing end-organ damage	30 days, 6 months, and 12 months

Trial Locations

Locations (3)

Erasmus MC Rotterdam; 🇳🇱 Rotterdam, Netherlands

Hopital Européen Georges Pompidou; 🇫🇷 Paris, France

Universitätskliniken Köln; 🇩🇪 Köln, Germany