Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180310
Status:
COMPLETED
Last Update Posted:
2011-07-20
First Post:
2005-09-11
Brief Title:
SPIRIT II A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions
Status:
COMPLETED
Status Verified Date:
2011-07
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:
SPIRIT II
Brief Summary:
Prospective randomized active-control single blind parallel two-arm multi-center clinical trial comparing XIENCE V Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS EXPRESS2 Paclitaxel Eluting Coronary Stent System
TAXUS EXPRESS2 Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific
TAXUS EXPRESS2 Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific
Detailed Description:
The SPIRIT II trial was a randomized single blind active control multi-center clinical evaluation Subject eligibility criteria were similar to SPIRIT III and enrollment duration overlapped between studies In this study 300 subjects 31 randomization XIENCE V EECSS TAXUS PECSS were enrolled at 31 sites outside the United States The primary endpoint was in-stent late loss at 6 months Secondary endpoints included clinical outcomes at months 1 6 and 9 months and 1 2 3 4 and 5 years angiographic results at 6 months and 2 years and IVUS results at 6 months and 2 years Follow-up through 3 years is currently available
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