Clinical Impact of DCB-based Versus DES-based Intervention in Patients With MVCAD (NCT07539324) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Impact of DCB-based Versus DES-based Intervention in Patients With MVCAD
892 participantsStarted 2026-04-15
Plain-language summary
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.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. 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).
✓. Target lesions suitable for treatment with either drug-eluting stents (DES) or drug-coated balloons (DCB).
✓. Patients who have voluntarily provided written informed consent and are willing and able to comply with all protocol-specified requirements.
Exclusion criteria
✕. 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.
✕. Patients with a known hypersensitivity or allergy to contrast media, L-605 Cobalt-Chromium (Co-Cr) alloy, PLA and PLGA polymers, shellac, Vitamin E-TPGS, paclitaxel, or sirolimus.
✕. Patients with a target lesion located within a saphenous vein graft (SVG) or an arterial graft.
✕. Patients with target vessels/lesions that are excessively tortuous, angulated, or severely calcified, such that pre-dilatation cannot be performed or has failed, making the application of the investigational medical device difficult.