Drug-Coated Balloon in Patients With High Bleeding Risk (NCT05221931) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Drug-Coated Balloon in Patients With High Bleeding Risk
South Korea1,359 participantsStarted 2022-07-29
Plain-language summary
DCB-HBR trial is prospective, multi-center, open-label, randomized controlled, noninferiority trial.
The aim of the study is to compare clinical outcomes of drug-coated balloon (DCB) with drug-eluting stent (DES) for treatment of de-novo coronary lesion in patients with high bleeding risk (HBR).
Who can participate
Age range
19 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
. Subject must be at least 19 years of age
. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
. Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve ≤0.80 requiring revascularization in de-novo coronary artery of reference vessel size ≥2.25 mm
. Patients with high bleeding risk: one or more of the criteria listed (1) Adjunctive oral anticoagulation treatment planned to continue after PCI (2) Age ≥ 75 years old (3) Baseline Hemoglobin \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) (4) Any prior intra-cerebral bleeding (5) Stroke at any time or transient ischemic attack in the previous 6 months. (6) Hospital admission for bleeding during the prior 12 months (7) Non skin cancer diagnosed or treated \< 3 years (8) Planned daily NSAID (other than aspirin) or steroids for \>30 days after PCI (9) Planned surgery that would require interruption of DAPT (within next 12 months) (10) Renal failure defined as calculated creatinine clearance \<40 ml/min or on dialysis (11) Hematological disorders (platelet count \<100,000/mm3 or any coagulation disorder) (12) Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice (13) Expected non-compliance to prolonged DAPT for other medical reasons
Exclusion criteria
. Patients unable to provide consent
. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
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 specifically for patients with high bleeding risk — how would my doctor determine whether I actually meet that criteria, and does my current bleeding risk level make this worth discussing?
2The trial uses a drug-coated balloon instead of a stent to treat coronary artery disease — can my doctor explain how a drug-coated balloon works differently from a stent, and why that approach might or might not make sense for my specific blockage?
3The trial is no longer actively recruiting but is still ongoing — does that mean results aren't available yet, and how should I weigh that uncertainty against choosing a standard treatment option that already has more known safety and outcome data?
4The primary outcome being measured is 'target vessel failure' — can my doctor explain what that means in plain terms, and what the current evidence suggests about how drug-coated balloons perform on that measure compared to other approaches for high bleeding risk patients?
5Since this trial is in a phase listed as 'NA' and focuses on a specific high-risk population, can my doctor help me understand whether my other health conditions or medications — especially anything affecting bleeding — might affect whether this kind of treatment approach would even be appropriate for me?
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 with angiographic findings of (1) Left main coronary artery disease (2) In-stent restenosis is the cause of target lesion (3) Target lesion in bypass graft (4) True bifurcation lesion that requires upfront 2-stenting
. Patients who have non-cardiac co-morbid conditions with life expectancy \<2 year
. Patients who may result in protocol non-compliance (site investigator's medical judgment)
. Patients with cardiogenic shock or cardiac arrest
. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)
. Patients with severe valvular heart disease requiring open heart surgery