|
LONG NAGOMI™ PMCF STUDY
RECRUITINGSponsored by Fundación EPIC
Actively Recruiting
SponsorFundación EPIC
Started2026-02-27
Est. completion2028-01-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07399002
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
Age: 18 Years+Healthy volunteers accepted
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.
Conditions3
Coronary Artery DiseaseHeart DiseaseIschemic Heart Disease
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
SponsorFundación EPIC
Started2026-02-27
Est. completion2028-01-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07399002