Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-30 @ 2:54 PM
Study NCT ID:
NCT01178268
Status:
COMPLETED
Last Update Posted:
2016-08-24
First Post:
2010-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
Status:
COMPLETED
Status Verified Date:
2016-07
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:
None
Brief Summary:
This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Eluting Coronary Stent System (SECSS) ("CYPHER SELECT PLUS") during commercial use in China.
Detailed Description:
Objectives
* Confirm the safety and effectiveness of the XIENCE V EECSS for the treatment of patients in China
* Evaluate patient compliance with dual antiplatelet therapy (DAPT)
* Evaluate physician-determined XIENCE V EECSS acute performance, deliverability, and resource utilization
* Confirm the safety and effectiveness of the XIENCE V EECSS for the treatment of patients in China
* Evaluate patient compliance with dual antiplatelet therapy (DAPT)
* Evaluate physician-determined XIENCE V EECSS acute performance, deliverability, and resource utilization
Study Oversight
Has Oversight DMC:
False
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?: