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Compares treatment options for Chronic Coronary Syndrome
Official title Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2
ClinicalTrials.gov ID: NCT06742931
What this study is testing
- What it's testing
- A prospective, multi-center, open-label, randomized controlled, and superiority trial. The trial will compare clinical outcomes between discontinuation of antiplatelet agent and continuation of antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty and standard duration of DAPT, followed by maintenance of single antiplatelet agent without clinical event for at least 1 year from the index procedure.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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 chronic coronary syndrome and at least one de novo lesion of reference vessel size ≥2.25 mm, treated with DCB angioplasty
- Patients with high bleeding risk: one or more of the criteria listed A. Age ≥ 75 years old B. Baseline Hemoglobin \ 30 days after PCI G. Planned...
- Patients who completed standard duration of DAPT (1-3months) and followed by maintenance of single antiplatelet agent (aspirin or P2Y12 inhibitor)...
You likely can't join if
- Patients unable to provide consent
- Patients with acute myocardial infarction or unstable angina
- Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of DCB
- Patients with indication of oral anticoagulant
- Patients with concomitant drug-eluting stent implantation during index PCI
- Patients with history of ischemic stroke or previous myocardial infarction
See the full eligibility 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 chronic coronary syndrome and at least one de novo lesion of reference vessel size ≥2.25 mm, treated with DCB angioplasty
- Patients with high bleeding risk: one or more of the criteria listed A. Age ≥ 75 years old B. Baseline Hemoglobin \ 30 days after PCI G. Planned surgery that would require interruption of DAPT (within next 12 months) H...
- Patients who completed standard duration of DAPT (1-3months) and followed by maintenance of single antiplatelet agent (aspirin or P2Y12 inhibitor) for at least 1 year from index procedure.
- No bleeding (BARC 2, 3, or 5 bleeding) or ischemic events (cardiovascular death, non-fatal MI, or clinically-indicated repeat revascularization) for at least 1 year from index procedure.
- Patients unable to provide consent
- Patients with acute myocardial infarction or unstable angina
- Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of DCB
- Patients with indication of oral anticoagulant
- Patients with concomitant drug-eluting stent implantation during index PCI
- Patients with history of ischemic stroke or previous myocardial infarction
- Patients with peripheral arterial occlusive disease
- Patients with angiographic findings of A. Left main coronary artery disease B. In-stent restenosis is the cause of target lesion C. Target lesion in bypass graft D. True bifurcation lesion that requires upfront...
- Patients who have non-cardiac co-morbid conditions with life expectancy \<1 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
- Pregnant or lactating women
The study team makes the final eligibility decision.
Where it's taking place
- Ansan, South Korea
- Daegu, South Korea
- Gangneung, South Korea
- Goyang, South Korea
- Gwangju, South Korea
- Gwangmyeong, South Korea
- Incheon, South Korea
- Jeonju, South Korea
- Jinju, South Korea
- Seoul, South Korea
- Suwon, South Korea
- Uijeongbu-si, South Korea
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ansan, South Korea; Daegu, South Korea; Gangneung, South Korea; Goyang, South Korea; Gwangju, South Korea; Gwangmyeong, South Korea and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.