| NCT ID | NCT07399002 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación EPIC |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,039 participants |
| Start Date | 2026-02-27 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,039 participants in total. It began in 2026-02-27 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Patients who meet ALL inclusion criteria will be included: * Patients aged ≥ 18 years AND; * Patients who according to standard practice of the hospital are amenable to PCI as indicated and considered adequate according to the European clinical practice guidelines on coronary revascularization AND; * Patients with at least one lesion fulfilling the "long lesion criteria" suitable for a single stent approach AND; * Patients who have been informed of the characteristics of the study and have provided written informed consent AND; * Intention to treat all lesions with the Ultimaster Nagomi™ stent Exclusion Criteria: * Patients must not meet any of the following exclusion criteria: * Patients who expressly decline to participate in the study. * Pregnant or breastfeeding women. * Patients with acute coronary syndrome (ACS) under conditions of cardiogenic shock (Killip class 4). * Patients with contraindications or hypersensitivity to sirolimus. * Patients with a life expectancy of less than 2 years. * Patients in whom any surgery requiring general anesthesia is planned, comorbidity or indication likely necessitating the discontinuation of dual anti-platelet therapy before the recommended duration of dual anti-platelet therapy per the ESC or national guidelines. * Patients included in other clinical trials that did not reach the primary objective.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07399002 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07399002 currently recruiting?
Yes, NCT07399002 is actively recruiting participants. Contact the research team at tgcamarero@gmail.com for enrollment information.
Where is the NCT07399002 trial being conducted?
This trial is being conducted at Cabueñes, Spain, Ciudad Real, Spain, Elche, Spain, Huelva, Spain and 6 additional locations.
Who is sponsoring the NCT07399002 clinical trial?
NCT07399002 is sponsored by Fundación EPIC. The trial plans to enroll 1,039 participants.