Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:16 PM
Study NCT ID:
NCT07399002
Status:
RECRUITING
Last Update Posted:
2026-03-13
First Post:
2025-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LONG NAGOMI™ PMCF STUDY
Sponsor:
Fundación EPIC
Organization:
Study Overview
Official Title:
Long Coronary Lesions: Safety and Performance of the Ultimaster Nagomi™ Stent in This Setting With a One-to-one Approach -One Lesion, One Stent- LONG NAGOMI™ PMCF STUDY
Status:
RECRUITING
Status Verified Date:
2026-03
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:
LONG NAGOMI
Brief Summary:
The study is designed as a prospective, multi-center, observational PMCF (post-market clinical follow-up) study of the Ultimaster Nagomi™ \_stent (lengths of 38, 44 and 50 mm) in the treatment of coronary artery disease according to the indications approved in the CE marking.
Detailed Description:
The study serves to fulfill post marketing surveillance requirements for the Ultimaster Nagomi™ stent. This is a PMCF study of real-world use of the Ultimaster Nagomi™ DES aimed to reaffirm the device claims of effectiveness and safety, no comparator is required to meet these specified objectives and endpoints.
Study Oversight
Has Oversight DMC:
True
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?: