Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00496938
Status:
COMPLETED
Last Update Posted:
2015-05-13
First Post:
2007-07-03
Brief Title:
XIENCE V SPIRIT WOMEN
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions
Status:
COMPLETED
Status Verified Date:
2015-05
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:
None
Brief Summary:
The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System XIENCE V and XIENCE PRIME EECSS with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions and the characterization of the female population undergoing stent implantation with a XIENCE stent
Detailed Description:
SPIRIT Women Single-Arm Study A prospective open label single arm multi-center study evaluating performance of the XIENCE V and XIENCE PRIME EECSS in the treatment of female patients with coronary artery lesions per its Instructions for Use IFU
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years the SPIRIT II trial up to 4 years and in the SPIRIT III Randomized Control Trial RCT up to 3 years In addition these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events MACE that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study This benefit in MACE is sustained for up to 5 years and is also independent of the first year results
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion exclusion criteria
Therefore based on existing data from these trials Abbott Vascular has decided to discontinue further follow up in the SPIRIT Women study after 2 years
The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years the SPIRIT II trial up to 4 years and in the SPIRIT III Randomized Control Trial RCT up to 3 years In addition these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events MACE that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study This benefit in MACE is sustained for up to 5 years and is also independent of the first year results
The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion exclusion criteria
Therefore based on existing data from these trials Abbott Vascular has decided to discontinue further follow up in the SPIRIT Women study after 2 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