LONG NAGOMI™ PMCF STUDY
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación EPIC
About this trial
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
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- LONG NAGOMI
Treatment groups
1,039 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov