Clinical Impact of DCB-based Versus DES-based Intervention in Patients With MVCAD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorGenoss Co., Ltd.
About this trial
This study aimes to compare the clinical outcomes of drug-coated balloon-based percutaneous coronary intervention (DCB-based PCI) and drug-eluting stent-based percutaneous coronary intervention (DES-based PCI) in patients with multivessel coronary artery lesions measuring 2.25 mm to 4.0 mm in diameter through a prospective, multicenter, active-controlled, randomized, investigator-initiated clinical trial.
Eligibility criteria
Qualifiers
Male or female adults aged 20 years or older with stable angina, silent myocardial ischemia, unstable angina, or non-ST-segment elevation myocardial infarction (NSTEMI).
In cases of ST-segment elevation myocardial infarction (STEMI), patients who have undergone successful primary percutaneous coronary intervention (PCI) without complications, at least 48 hours post-procedure, and whose target lesion(s) show no evidence of thrombus.
Patients with multivessel coronary artery disease, defined as angiographic stenosis of 50% in at least two major epicardial coronary arteries requiring PCI as determined by the investigator.
Reference vessel diameter (RVD) of the target lesion(s) between 2.25 mm and 4.0 mm by visual estimation or quantitative coronary angiography (QCA).
Disqualifiers
Cardiogenic shock or patients requiring mechanical or pharmacological circulatory support.
Patients with a life expectancy of less than 2 years due to comorbid conditions.
Patients who are currently participating or planning to participate in other interventional clinical trials, excluding observational studies.
Women who are pregnant or have childbearing potential.
Trial design
Treatments tested in this trial
- GENOSS® DCB (Paclitaxel-coated PTCA balloon catheter)
- Second, Third Generation Drug-Eluting Coronary Stent System
Treatment groups
892 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov