comparison of safety and efficacy of coronary drug-coated balloon (dcb) combined with spot stenting of drug-eluting stent (des) versus second-generation des for treating diffuse coronary artery lesions: a prospective, randomized, controlled clinical trial

Conditions: Diffuse Coronary Artery Lesions

Summary: the prospective, randomized, controlled clinical trial aims to evaluate the safety and efficacy of paclitaxel-eluting ptca-balloon catheter (sequent® please) combined with provisional spot stenting of des versus des for treating diffuse coronary artery lesions concerning interventional therapy and vessel patency.


Eligibility criteria:
inclusion criteria: * patient-related * patients who have typical angina pectoris symptoms with obvious evidence of ischemia; * patients whose ages are between 18-80 years; * patients who must agree to receive a 9-month angiographic follow-up; * patients who must agree to receive clinical follow-up of 30 days, and 3, 6, 9, 12, 24 and 36 months; * patients who can understand the purpose of this study both psychologically and linguistically, demonstrating sufficient compliance to the study protocol; * patients who express their recognition of the risks and benefits described in the informed consent form by providing their inform consent; * lesion-related * diffuse coronary artery disease in situ; * reference target vessel diameter of 2.5-4.0 mm and length of \> 25 mm; * non-target vessel lesions needing to receive a successful intervention therapy first before randomization to receive treatment for target lesions (note: within the same hospitalization); * visually estimated diameter stenosis of ≥70%, or diameter stenosis of ≥50% with objective evidences of ischemia (treadmill exercise testing, ect or ffr\<0.8) exclusion criteria: * patient-related: * patients who have the attack of myocardial infarction within the past week, or whose troponin fails to return to normal although myocardial infarction has occurred for over one week; * patients with serious congestive heart failure or nyha iv-level serious heart failure; * patients whose left ventricular ejection fraction is \< 30%; * patients who have medical history of stroke or tia within 6 months prior to the surgery; * patients who have a current or previous history of serious liver failure and thereby fail to meet the requirements of angiography; * patients who have a current or previous history of serious kidney failure (gfr\<30 ml/min) and thereby fail to meet the requirements of angiography; * patients who have a previous history of intracranial neoplasms, aneurysm, arteriovenous malformation or cerebral hemorrhage; * patients whose life expectancy does not exceed 1 year or who are difficult to follow up clinically; * patients who have been scheduled to undergo elective surgery which may lead to the early discontinuation of adp receptor antagonists; * pregnant or lactating women or women who are planning to become pregnant during the study. * patients participating in any other clinical trial; * patients who are considered not suitable for inclusion by the investigator for any other reason; * lesion-related: * patients who have the evidence of extensive thrombosis in target vessels prior to the interventional therapy; * patients who have left main coronary artery disease or graft lesions needing to be treated; * patients who have bifurcation lesions with a side-branch vessel diameter of \>2.5 mm; * patients who have lesions at the ostia of coronary artery, at the circumflex branch, at the ostia of anterior descending branch or within 5 mm at the ostia of coronary artery; * severe intimal tear disease; * in-stent restenosis; * lesions which can not be treated with ptca or other intervention technologies; * lesions with serious calcification; * concomitant medication related * patients who have a physique prone to hemorrhage and are prohibited from taking anticoagulants or antiplatelet drugs; * patients who can not tolerate aspirin and/or clopidogrel, or who have serious hypohepatia and must not use clopidogrel; * patients who can not tolerate or have known allergy to heparin, contrast media, paclitaxel, iopromide, rapamycin, poly(lactic-co-glycolic acid) polymers or stainless steel, etc,; * patients with a history of leukopenia (with wbc\<3×109/l for more than 3 days), neutropenia (with anc \<1,000 cells/mm3 for more than 3 days), or thrombocytopenia (with platelet count \<100,000/mm3);