Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235066
Status:
COMPLETED
Last Update Posted:
2008-09-16
First Post:
2005-10-06
Brief Title:
The CYPHER Stent Study in Patients With Small de Novo Coronary Artery Lesions
Sponsor:
Cordis Corporation
Organization:
Cordis Corporation
Study Overview
Official Title:
A Multicenter Nonrandomized Historical Controlled Study In Patients With De Novo Coronary Artery Lesions In Small VessELs Treated With The CYPHER STEnt
Status:
COMPLETED
Status Verified Date:
2008-09
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:
SVELTE
Brief Summary:
The main objective of this study is to assess the effectiveness of the CYPHER sirolimus-eluting stent in reducing in-lesion late lumen loss in de novo native coronary artery lesions in small vessels 225 - 275 mm as compared to the small vessel tercile of the uncoated Bx VELOCITYTM Stent patients from the SIRIUS Trial using a stenting technique that minimizes balloon trauma to the vessel and assures full coverage of the lesion with the stent
Detailed Description:
This is an international multicenter up to 10 sites nonrandomized historically controlled study in patients with De Novo coronary artery lesions in small vessels treated with the CYPHER sirolimus-eluting stent as compared to the small vessel tercile uncoated Bx VELOCITYTM Stent patients from the SIRIUS Trial A total of up to 100 patients will be enrolled in this study
Patients with de novo native coronary artery lesions 15mm and 30mm in length and 225 mm to 275 mm in diameter by visual estimation will be treated with the CYPHER sirolimus-eluting stent Patients will be followed at 30 days 6 8 9 months and at 1 2 and 3 years post-procedure with a repeat angiography at 8 months In all patients Intravascular Ultrasound IVUS will be performed before only in case of crossing success and after the initial procedure An IVUS control will also be done at 8 months follow up to assess neo-intimal growth and remodeling
This is a single lesion treatment study Patients may have other lesions treated before the treatment of the intended lesion in the small vessel a non-target lesion may not be located in the target vessel Post-procedural treatment of another lesion is only allowed after the 30-day follow-up contact has been completed or in case this is clinically needed
It is anticipated that the total length of the study will be 39 months 3 months to complete patient enrollment and 3 years for follow-up
Patients with de novo native coronary artery lesions 15mm and 30mm in length and 225 mm to 275 mm in diameter by visual estimation will be treated with the CYPHER sirolimus-eluting stent Patients will be followed at 30 days 6 8 9 months and at 1 2 and 3 years post-procedure with a repeat angiography at 8 months In all patients Intravascular Ultrasound IVUS will be performed before only in case of crossing success and after the initial procedure An IVUS control will also be done at 8 months follow up to assess neo-intimal growth and remodeling
This is a single lesion treatment study Patients may have other lesions treated before the treatment of the intended lesion in the small vessel a non-target lesion may not be located in the target vessel Post-procedural treatment of another lesion is only allowed after the 30-day follow-up contact has been completed or in case this is clinically needed
It is anticipated that the total length of the study will be 39 months 3 months to complete patient enrollment and 3 years for follow-up
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