Actively Recruiting
Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease
Led by Bon-Kwon Koo · Updated on 2023-10-27
500
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
B
Bon-Kwon Koo
Lead Sponsor
S
Seoul National University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of drug-coated balloons (DCBs) in treating coronary artery lesions in patients with multivessel coronary artery disease (MVD). This observational, open-label, multicenter study compares the impact of a hybrid treatment strategy using both drug-coated balloons and drug-eluting stents (DES) against the conventional approach of using only drug-eluting stents. The study aims to understand how clinical practices change toward this hybrid strategy and its effects on patient outcomes. Participants receive percutaneous coronary intervention either with a combination of drug-coated balloons and drug-eluting stents or with drug-eluting stents alone to treat their coronary artery lesions. The drug-coated balloons used are suitable for both new coronary lesions and in-stent restenosis, while the drug-eluting stents are of the latest second generation, applied according to current guidelines. Patients follow their assigned treatment during the procedure without additional intervention phases. During the study, researchers will monitor changes in treatment patterns and clinical outcomes such as cardiovascular death, myocardial infarction, revascularization rates, and bleeding events over one year. The main measurement is the reclassification rate of the treatment strategy at the time of the procedure. Participants will be followed for one year to assess these outcomes and safety measures, helping to evaluate the impact of the hybrid DCB and DES approach on treating multivessel coronary artery disease.
CONDITIONS
Brief Title
Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Diagnosis of multivessel coronary artery disease requiring coronary intervention
- Stenosis of two or more major coronary arteries or branches with vessel size 2.5mm or larger and diameter stenosis of 50% or more, or fractional flow reserve 0.80 or less requiring repeat revascularization
- Having stenotic lesions needing revascularization with vessel size between 2.5mm and 3.0mm
- Ability to understand risks and benefits and provide informed consent
You will not qualify if you...
- Unable to voluntarily provide informed consent
- Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
- Cardiogenic shock or cardiac arrest
- Severe left ventricular systolic dysfunction (ejection fraction less than 30%)
- Patients prioritized for coronary artery bypass surgery over intervention
- Severe valvular heart disease requiring open heart surgery
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day
Participants undergo percutaneous coronary intervention using drug-coated balloons and/or drug-eluting stents for their coronary artery lesions.
1 visit (in-person)
Duration - 1 year
Participants are observed and monitored for up to one year after the procedure for cardiovascular events and treatment outcomes.
Periodic visits over 1 year
Trial Site Locations
Total: 1 location
1
Bon-Kwon Koo
Seoul, South Korea
Actively Recruiting
Research Team
B
Bon-Kwon Koo, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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