Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD
NCT05750771
Summary
The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly coronary arteries. And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.
Eligibility
Inclusion Criteria: * 1\. older than 60 years of age. * 2\. meeting the indications for coronary intervention. * 3\. IVUS examination suggests severe calcified lesions (calcification angle \> 270° at the target lesion) or OCT examination suggests severe calcified lesions (calcification angle \> 180° and/or length \> 5 mm and/or thickness \> 0.5 mm); * 4\. Target lesion vessel diameter \> 2.5 mm Exclusion Criteria: * 1\. inability to provide written informed consent. * 2\. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc. * 3\. the subject is participating in another uncompleted clinical trial * 4\. life expectancy \<1 year. * 5\. non-in situ vascular lesions. * 6\. cardiogenic shock. * 7\. Patients with hemodynamic instability
Conditions2
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NCT05750771