Actively Recruiting
Procedural Success and Outcomes of Drug-Coated Coronary Balloons in Various Clinical Scenarios
Led by Kutahya Health Sciences University · Updated on 2026-01-13
1500
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Kutahya Health Sciences University
Lead Sponsor
P
Pamukkale University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of drug-coated balloons (DCBs) in treating various types of coronary artery disease, including in-stent restenosis, small vessel disease, de novo lesions, chronic total occlusions, and bifurcation lesions. This observational registry aims to gather real-world data on the safety, feasibility, and clinical outcomes of DCB angioplasty across diverse coronary lesion types and patient presentations in Turkey. The study seeks to provide comprehensive evidence beyond traditional uses, addressing both short- and long-term success rates. The study includes patients undergoing percutaneous coronary intervention (PCI) where DCBs are used either alone or with bailout stenting. Detailed information about patient demographics, clinical history, angiographic and procedural details, lesion preparation methods, intravascular imaging, and DCB characteristics will be collected. The registry will analyze procedural success and clinical outcomes such as major adverse cardiovascular events and need for further revascularization, focusing also on the role of lesion preparation and imaging guidance. Participants will be followed for at least 12 months, with data collected on death, revascularization of target lesions and vessels, myocardial infarction, bleeding events, and procedural success. Researchers will monitor clinical progress, collect angiographic and procedural data, and evaluate outcomes to identify factors influencing success or failure of DCB use. This study reflects routine clinical practice and aims to inform future randomized trials comparing DCB strategies with drug-eluting stents.
CONDITIONS
Brief Title
Drug-Coated Coronary Balloons in Different Clinical Scenarios
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with coronary artery disease undergoing PCI with drug-coated balloon treatment for at least one lesion
- DCB use allowed in stable coronary disease and acute coronary syndromes
- Treatment for different lesion types including de novo, in-stent restenosis, bifurcation, small and large vessels, and chronic total occlusions
- Successful lesion preparation with residual stenosis ≤30% and no flow-limiting dissection before DCB inflation
- Availability of baseline clinical, angiographic, and procedural data
- Ability to provide informed consent or data availability per local rules
- Planned clinical follow-up
You will not qualify if you...
- Primary treatment without drug-coated balloon (e.g., only drug-eluting stent implantation)
- Cardiogenic shock during the procedure
- Life expectancy less than 1 year due to non-cardiac conditions
- Contraindication to antiplatelet therapy
- Known severe allergy to contrast media not manageable with premedication
- Pregnancy
- Inability to comply with clinical follow-up
- Participation in another interventional clinical trial that may affect outcome assessment
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.
1 visit (in-person)
Duration - 12 months
Participants who undergo routine care with drug-coated balloon treatment are observed to evaluate procedural success and clinical outcomes.
Approximately 3 to 4 follow-up visits over 12 months
Trial Site Locations
Total: 5 locations
1
Pamukkale University
Denizli, Turkey (Türkiye)
Actively Recruiting
2
Bahcelievler Memorial Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
3
Bezmialem Vakıf Universitesi
Istanbul, Turkey (Türkiye)
Actively Recruiting
4
Goztepe Medicalpark Hastanesi
Istanbul, Turkey (Türkiye)
Actively Recruiting
5
Kutahya City Hospital
Kütahya, Turkey (Türkiye)
Actively Recruiting
Research Team
F
Fatih Kahraman, Associate Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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