About this trial
Coronary stents are the best treatment method ever accepted in the treatment of coronary artery stenoses. Due to some limitations and complications of stent use, the operators tried to find new solutions. Drug Coated Balloons (DCBs) have been accepted as a new method in the treatment of in-stent restenosis and small vessel disease. Furthermore, they have been used in the treatment of de novo coronary lesions, chronic total occlusions and bifucation lesions. But data is limited in the short and long term success of DCBs in all these clinical scenarios. In our study we aimed to investigate the procedural success and short and long term outcomes of DCB use in different clinical scenarios.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The study population will consist of adult patients (≥18 years) with coronary artery disease who undergo percutaneous coronary intervention (PCI) in routine clinical practice in participating centers and are treated with a drug-coated balloon (DCB) for at least one target coronary lesion. The registry will include patients across a broad spectrum of clinical presentations, including stable coronary artery disease and acute coronary syndromes, and will encompass a wide range of lesion subsets such as de novo lesions, in-stent restenosis, bifurcation lesions, small and large vessels, and chronic total occlusions. Both prospectively and retrospectively enrolled patients will be included, reflecting real-world practice without additional diagnostic or therapeutic interventions beyond standard of care. The population will therefore represent an unselected, all-comer cohort treated with contemporary DCB-based strategies, allowing comprehensive evaluation of clinical and procedural outcomes.
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Death, target lesion revascularization, target vessel revascularization, myocardial infarction
Cardiac or noncardiac death events will be recorded during follow up. Forthermore, target vessel or lesion revascularization, myocardial infarction will be recorded according to the previously described criteria.
Secondary outcomes
Angina, target vessel revascularization, Procedural success and need for bailout stenting, Major bleeding (BARC ≥3)
Assessment of symptomatic angina status, need for repeat revascularization of the target vessel, procedural success including the requirement for bailout stent implantation, and the occurrence of major bleeding events defined as Bleeding Academic Research Consortium (BARC) type ≥3.
Sponsors and contacts
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Kutahya Health Sciences University
Lead sponsor
Pamukkale University
Collaborator
Memorial Bahçelievler Hospital
Collaborator
Bezmialem Vakif University
Collaborator
Dicle University
Collaborator
Ordu University
Collaborator
Adana City Training and Research Hospital
Collaborator
Marmara University
Collaborator
Trakya University
Collaborator
Kafkas University Health Research and Application Hospital
Collaborator
Selcuk University
Collaborator
Istanbul University - Cerrahpasa
Collaborator