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临床试验/NCT07794839
NCT07794839招募中不适用

The Role of Drug Coated Balloons in the Treatment of Coronary Artery Disease: an Observational Nationwide Experience

Istanbul Mehmet Akif Ersoy Educational and Training Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
target lesion failure

研究概览

简要总结

Evaluation of the efficacy and clinical outcomes of drug-eluting balloon therapy in ticyaici coronary artery disease.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

drug eluting stent

lesions treated with drug eluting stent

干预措施: drug eluting stent (Device)

drug coated balloon

lesions treated with drug coated balloon

干预措施: drug coated balloon (Device)

结局指标

主要结局

target lesion failure

时间窗: 12 month

composite endpoint of target lesion revascularization, target vessel myocardial infarction and cardiac death

次要结局

未报告次要终点

研究者

发起方
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Serkan Kahraman

Profesor, MD

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

研究点 (1)

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