Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232869
Status:
COMPLETED
Last Update Posted:
2010-02-04
First Post:
2005-10-04
Brief Title:
A Study of the SMART Stent in the Treatment SFA Disease
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
A Clinical Investigation of the SIROlimus Coated Cordis SMART Nitinol Selfexpandable Stent for the Treatment of Obstructive Superficial Femoral Artery Disease
Status:
COMPLETED
Status Verified Date:
2010-02
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:
SIROCCO
Brief Summary:
The main objective of this study is to assess the safety and performance of the sirolimus coated Cordis SMART nitinol self expandable stent device and its delivery system in the treatment of obstructive superficial femoral artery SFA disease in reducing percent in-stent mean lumen diameter stenosis in de novo or restenotic native lesions as compared to the uncoated SMART stent
Detailed Description:
This is a multi-center prospective randomized double blind two-arm feasibility study evaluating the safety and performance of the sirolimus coated Cordis SMART nitinol self-expanding stent and delivery system as compared to the uncoated SMART stent and delivery system It is anticipated that a total of 90 patients will be entered into the study Patients will be randomized on a 11 basis of coated to uncoated stents
Ninety 90 patients with de novo or restenotic native SFA lesions will be randomized to the Sirolimus Coated SMART nitinol self-expanding stent or to the uncoated bare SMART stent
Patients will be followed for 24 months post-procedure with all patients having duplex ultrasound and clinical assessments at discharge 1 6 9 18 and 24 months angiography at 6 six months and plain X-ray at 18 months This study will be conducted at nine investigational sites Protocol was amended where 56 additional patients were recruited and followed for up to 5 years
Ninety 90 patients with de novo or restenotic native SFA lesions will be randomized to the Sirolimus Coated SMART nitinol self-expanding stent or to the uncoated bare SMART stent
Patients will be followed for 24 months post-procedure with all patients having duplex ultrasound and clinical assessments at discharge 1 6 9 18 and 24 months angiography at 6 six months and plain X-ray at 18 months This study will be conducted at nine investigational sites Protocol was amended where 56 additional patients were recruited and followed for up to 5 years
Study Oversight
Has Oversight DMC:
None
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?:
None