Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-01-01 @ 10:43 PM
Study NCT ID:
NCT02986295
Status:
UNKNOWN
Last Update Posted:
2018-02-09
First Post:
2016-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent
Sponsor:
Hyeon-Cheol Gwon
Organization:
Study Overview
Official Title:
Real World Drug-Eluting Stent Prospective, Open, Multi-site, Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent By SMart Angioplastry Research Team (SMARTDESK-MX)
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
RECRUITING
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:
SMARTDESK-MX
Brief Summary:
Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with Xience® stent
Detailed Description:
A prospective, open, multicenter, and observational study will register and compare Xience® groups treated in institutions such as the BioMime ™, Ultimaster® group prospectively registered from June 2016.
The Xience® group has already been registered in the previous study (SMARTDESK-BX), so BioMimeTM and Ultimaster® only need to be registered. Follow-up will be conducted until December 2019, and e-CRF will be completed by April 2020.
The Xience® group has already been registered in the previous study (SMARTDESK-BX), so BioMimeTM and Ultimaster® only need to be registered. Follow-up will be conducted until December 2019, and e-CRF will be completed by April 2020.
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?: