Drug-Coated Coronary Balloons in Different Clinical Scenarios

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKutahya Health Sciences University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

1,500 Participants
are grouped into 1 trial group
Group A: Coronary artery disease

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 months

Other outcomes

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