NCT00235157

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

Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Sirolimus-eluting Palmaz Genesis peripheral stent	treatment of renal artery stenosis with a renal stent

Timeline

• Start date: 2001-11-01
• Primary completion: 2002-11-01
• Completion: 2005-07-01
• First posted: 2005-10-10
• Last updated: 2008-08-06

Locations

3 sites across 3 countries: France, Germany, Netherlands