University of Health Sciences, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Center, Training and Research Hospital, Department of Cardiology
Istanbul, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07794839
Evaluation of the efficacy and clinical outcomes of drug-eluting balloon therapy in ticyaici coronary artery disease.
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Observational
Istanbul, Turkey (Türkiye)
Location status: Recruiting
Coronary artery lesions are a clinical condition of increasing importance, especially in recent years. Due to their complex anatomy and the need for high operator experience, the optimal treatment strategy remains a subject of debate. While drug-eluting stent therapy is a proven treatment method for these patients, drug-eluting balloon angioplasty, which has become increasingly common in recent years, is also an important alternative. Percutaneous interventional treatment approaches for complex coronary artery disease continue to be a subject of research due to their lower success rates, as well as their association with higher complications and adverse cardiovascular outcomes. Particularly in recent years, the encouraging results of drug-eluting balloon angioplasty (DCB) therapy applied in the treatment of de novo coronary artery disease have led to the publication of results regarding the use of DCB in bifurcation lesions (1-3). In bifurcation patients who underwent provisional stenting, a reduction in adverse clinical outcomes was observed in 1-year follow-ups with side branch drug-eluting balloon angioplasty (1). Following the positive outcomes of DCB treatment in patients with true bifurcation lesions, patients who underwent provisional stenting and side branch DCB placement were compared in many studies with patients treated with drug-eluting stents (provisional or double stent strategy). The common result of these studies is that while acute side branch lumen patency was significantly lower in patients treated with DCB compared to the side branch stent group, there was no difference in clinical outcomes between the two groups in long-term clinical follow-up. Furthermore, there are studies showing that long-term lumen loss and TLR were lower in the DCB-treated group compared to the 2-stent group (1-3). In addition, a study in non-LMCA bifurcations found that in patients requiring side branch intervention after provisional stenting, side branch intervention with DCB had better long-term clinical outcomes, particularly regarding spontaneous myocardial infarction, compared to non-compliant coronary balloons (1). In our study, we will examine the development of clinical events in coronary artery disease patients treated with drug-eluting balloon angioplasty.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
1- Patients aged 18 years and older; 2- Patients with silent ischemia, chronic coronary syndrome, or ACS; 3- Patients treated with drug-eluting balloon angioplasty.
Exclusion criteria
1- Patients with ST-segment elevation myocardial infarction and/or cardiogenic shock; 2- Patients with graft vessels from CABG surgery; 3- Patients who are contraindicated from dual antiplatelet therapy; 4- Patients with a life expectancy of less than 1 year; 5- Pregnant patients; 6- Patients with active bleeding, hematological disease, or cancer; 7- Patients unable to attend clinical follow-ups; 8- Patients with planned surgery within the next 12 months.
patients treated with drug coated balloon dilatation
patients treated with drug eluting stent implantation
Time frame: 12 month
composite endpoint of target lesion revascularization, target vessel myocardial infarction and cardiac death
Contact information is provided by the study sponsor or research team.
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Other Gov
The Role of Drug Coated Balloons in the Treatment of Coronary Artery Disease: an Observational Nationwide Experience
Acronym: DCB-ONE TR
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