Trials / Recruiting
RecruitingNCT07399002
LONG NAGOMI™ PMCF STUDY
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,039 (estimated)
- Sponsor
- Fundación EPIC · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LONG NAGOMI | Patients in whom treatment with long nagomi has been attempted |
Timeline
- Start date
- 2026-02-27
- Primary completion
- 2028-01-01
- Completion
- 2029-01-01
- First posted
- 2026-02-10
- Last updated
- 2026-04-13
Locations
6 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT07399002. Inclusion in this directory is not an endorsement.