Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary … (NCT05846893) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
Malaysia, Singapore, South Korea1,436 participantsStarted 2023-09-07
Plain-language summary
Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease.
Who can participate
Age range
18 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
. Patient must be ≥ 18 years of age
. Patient is able to verbally confirm understanding of the study aim, risks, benefits, and treatment alternatives of receiving DCB or DES and he/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure
. (i) Clinical evidence of angina, and/or (ii) an abnormal functional study demonstrating myocardial ischemia due to the target lesion(s), or (iii) acute coronary syndrome \[unstable angina or non-ST-elevation myocardial infarction (NSTEMI) or uneventful STEMI (≥ 48 hours after primary PCI and no sign of thrombus in lesion(s) to treat)\]
. Patient with lesions suitable for PCI with a DCB (and/or DES) according to the Instructions for Use
. Patient is able to comply with the study protocol and agrees to undergo the clinical follow-up of 30 days, 6 months, 12 months, 24 months, and 36 months
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.
1This trial is comparing a drug-coated balloon to a drug-eluting stent for large coronary artery disease — can you explain the key difference between these two approaches, and why it might matter for my specific situation?
2The trial is measuring something called a 'Net Adverse Clinical Event' — what does that actually include, and what does it tell us about how safe or effective each treatment is?
3Since this trial is listed as 'active, not recruiting,' I can't join it right now — but based on what it's studying, is a drug-coated balloon already an option my care team would consider for me, or is a stent still the standard approach?
4This trial covers several conditions including acute coronary syndrome and stable coronary stenosis — given my specific diagnosis, which category do I fall into, and does that affect which treatment option might be better for me?
5If the results from this trial aren't yet published, how does my care team currently decide between a drug-coated balloon and a drug-eluting stent, and is there other existing evidence we should discuss before making that choice?
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.
. Presence of significant de novo large vessel coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation) with either ≥ 70% diameter stenosis or intermediate ≥ 50% to \<70% diameter stenosis with abnormal functional test or symptom of ischemia
. Successful lesion preparation. For randomisation, the lesion must satisfy the following criteria after optimal balloon angioplasty: no flow-limiting dissection (TIMI=3), and residual stenosis is ≤ 30%
Exclusion criteria
. Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: Iopromide)
. Severe allergy to contrast media
. Recent STEMI (ongoing or \< 48 hours after primary PCI and/or has sign of thrombus in lesion(s) to treat)
. NSTEMI hemodynamically unstable
. Known left ventricular ejection fraction of \<30%
. Inability to take dual antiplatelet therapy or anticoagulation, or single antiplatelet therapy for at least six months
. Non-cardiac co-morbid conditions that may result in protocol non-compliance and inability of patient to complete the study (per the site investigator's medical judgment)
. Patient with concomitant medical illnesses that require cytostatic, radiation therapy or renal replacement therapy