Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 12:40 AM
Study NCT ID:
NCT01115933
Status:
COMPLETED
Last Update Posted:
2015-08-13
First Post:
2010-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
SPIRIT PRIME JAPAN (SV JAPAN)
Status:
COMPLETED
Status Verified Date:
2015-06
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:
SV JAPAN
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease caused by de novo lesions.
Detailed Description:
None
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?: