Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-01 @ 6:00 PM
Study NCT ID:
NCT02539966
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2015-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
Sponsor:
REVA Medical, Inc.
Organization:
Study Overview
Official Title:
Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
Status:
COMPLETED
Status Verified Date:
2025-04
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:
FANTOM II
Brief Summary:
The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: