A not yet recruiting LONG NAGOMI PMCF study for coronary disease is listed publicly and tracked for regulatory oversight under MDR guidance.
As of February 11 2026, the ClinicalTrials.gov record for the LONG NAGOMI PMCF study lists the conditions coronary artery disease and ischemic heart disease, the intervention device LONG NAGOMI, and sponsorship by Fundación EPIC with a status of Not yet recruiting.
What is the LONG NAGOMI PMCF study?
The entry describes a PMCF study for a coronary device. It identifies the conditions Coronary Artery Disease and Ischemic Heart Disease, the device LONG NAGOMI, and sponsor Fundación EPIC. It also notes the status Not yet recruiting and provides a ClinicalTrials.gov identifier NCT07399002. The information comes from the ClinicalTrials.gov record as listed on this page.
What conditions are addressed and what device is studied?
Conditions: Coronary Artery Disease; Ischemic Heart Disease. Intervention: LONG NAGOMI device. Sponsor: Fundación EPIC. Recruitment status: Not yet recruiting. The ClinicalTrials.gov entry for NCT07399002 is the source for these details and the not yet recruiting status.
What regulatory context applies to this PMCF study?
The study is listed as a PMCF trial on ClinicalTrials.gov and is being tracked in the context of device regulatory oversight. The record identifier is NCT07399002. A link to the source is provided below for readers seeking the official record.
External link: https://clinicaltrials.gov/study/NCT07399002?term=medical+device
What is the current status and what are the next steps for stakeholders?
The status shown on ClinicalTrials.gov is Not yet recruiting. That flag indicates preliminary activity before site initiation. Stakeholders may monitor the record for updates and prepare regulatory and quality oversight as required under MDR and local guidelines.
What does this mean for regulators and sponsors?
Noting the Not yet recruiting status, regulators and sponsors should prepare for future updates when sites are ready. Readers should track the ClinicalTrials.gov entry and the sponsor plan for post market data collection and safety monitoring.
Disclaimer for professionals
This article provides professional level information and is not legal advice. For guidance on MDR requirements and national regulations seek counsel and refer to official regulatory texts.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07399002?term=medical+device
- Question 1 What is the LONG NAGOMI PMCF study? The LONG NAGOMI device is studied in a PMCF trial for coronary disease per the listed conditions.
- Question 2 Who sponsors the study? Fundación EPIC sponsors the study and its status Not yet recruiting is shown in the record NCT07399002.
What does this mean for regulators and sponsors?
Noting the Not yet recruiting status, regulators and sponsors should monitor for updates and plan for potential data collection and safety monitoring as the study progresses toward site activation.
Disclaimer for professionals
This article is intended for professionals and is not legal advice. For regulatory guidance consult MDR requirements and national regulations.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07399002?term=medical+device