Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-02 @ 9:37 PM
Study NCT ID:
NCT02009956
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2013-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EXCELLA Post-Approval Study
Sponsor:
Elixir Medical Corporation
Organization:
Study Overview
Official Title:
POST MARKETING STUDY OF THE ELIXIR DESyne® NOVOLIMUS ELUTING CORONARY STENT SYSTEM AND THE DESyne® BD NOVOLIMUS ELUTING CORONARY STENT SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS
Status:
COMPLETED
Status Verified Date:
2021-04
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:
To evaluate long-term safety and performance of the DESyne Novolimus Eluting Coronary Stent System and the DESyne BD Novolimus Eluting Coronary Stent System
Detailed Description:
DESyne and DESyne BD are not currently approved for sale in the United States.
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?: