Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-25 @ 4:14 PM
Study NCT ID:
NCT00235157
Status:
COMPLETED
Last Update Posted:
2008-08-06
First Post:
2005-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of Coated and Uncoated Stents in Renal Artery Treatment.
Sponsor:
Cordis US Corp.
Organization:
Study Overview
Official Title:
Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent, Comparing a Sirolimus Coated Versus an Uncoated Stent in REnal Artery Treatment.
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GREAT
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.
It is anticipated that the total length of time required to complete the study will be 46 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: