Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04591938
Status:
RECRUITING
Last Update Posted:
2020-10-19
First Post:
2020-10-06
Brief Title:
FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo CAD the ENCORE-I Study
Sponsor:
Joost Daemen
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Safety and Efficacy of the FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo Coronary Artery Disease the ENCORE-I Study
Status:
RECRUITING
Status Verified Date:
2020-10
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:
Prospective multicentre non-randomized investigator-initiated study aiming to assess the safety and efficacy of the Fantom Encore sirolimus-eluting bioresorbable scaffold BRS
Detailed Description:
Up to 50 consecutive participants with de-novo non-complex obstructive coronary lesions and non-ST elevation acute coronay syndromes or stable angina pectoris will be included in the Netherlands and Belgium
Device performance and behaviour will be assessed by angiography and optical coherence tomography at the index procedure and at 13 months follow-up
Device performance and behaviour will be assessed by angiography and optical coherence tomography at the index procedure and at 13 months follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None