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 range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.