Coronary heart disease
Conditions
Interventions
Group 1:Drug coated balloon angioplasty
Group 2:Percutaneous coronary intervention with sten
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Related to the subject; 2. Subjects with stable angina or unstable angina, or with old myocardial infarction or evidence of asymptomatic ischemia; 3. Subjects must be between 18 and 80 years of age; 4. Women of childbearing age are not pregnant or have plans to become pregnant during the study period. Subjects are advised to use adequate contraceptive measures until (including) the end of follow-up; 5. Subjects must agree to undergo a 9-month angiographic follow-up and 30-day, 6-month, 9-month, and 12-month clinical follow-up; 6. Subjects are psychologically and linguistically able to understand the purpose of the study, showing sufficient adherence to the study protocol; 7. Subjects expressed their consent to the risks and benefits described in the informed consent document by providing informed consent; 8. Associated with lesions The target lesion is primary, in situ coronary lesion, located on one or two different coronary vessels, and the number of target lesions on each coronary artery is no more than one; 9. Reference vessel diameter = 2.75mm; (visual inspection); 10. Non-target vascular lesions require prior interventional therapy (must be treated at the same time), and randomized and target lesions are treated after successful treatment; 11. Stenosis before surgery must be =70% or =50% with ischemia; (visual); 12. Only one SeQuent Please or drug stent can be used for each target lesion.
Exclusion criteria
Exclusion criteria: 1. Related to the subject; 2. Subjects with myocardial infarction within one week or subjects whose myocardial infarction occurred more than one week but troponin has not returned to normal; 3. Subjects with severe congestive heart failure or NYHA class IV severe heart failure; 4. Subject with severe valvular heart disease; 5. Pregnant or lactating women; 6. Subjects with a life expectancy of no more than 1 year or who have difficulty in clinical follow-up; 7. Subjects with cerebral stroke within 6 months prior to surgery; 8. Existing or have a history of severe liver failure, and therefore do not meet the conditions of angiography; 9. Existing or have a history of severe renal failure (eGFR < 30 ml / min), and therefore do not meet the conditions of angiography; 10. Heart transplant subject; 11. Cardiogenic shock subject; 12. Subjects with a left ventricular ejection fraction of less than 30%; 13. Coronary artery spasm without significant stenosis; 14. Other reasons that the investigator considered unsuitable for inclusion; 15. Associated with lesions; 16. Evidence of extensive thrombosis in the target vessel prior to intervention; 17. Percutaneous coronary intervention of a vein graft; 18. Chronic total occlusive disease (preoperative TIMI grade 0 blood flow); 19. Left main lesions or three-vessel lesions that need to be treated, branch vessels require interventional treatment of bifurcation lesions and vascular lesions; 20. Non-target lesions in the same blood vessel; 21. Distorted target vessel or presence of calcified lesions; 22. a lesion within 5 mm of the coronary artery opening; 23. After pre-expansion of the target lesion, the residual stenosis is =30% or the TIMI blood flow is <3, and/or the C-type or C-type interlayer is present; 24. Related to combined medication; 25. Subjects with bleeding constitution, banned anticoagulant or antiplatelet drugs; 26. Subjects who cannot tolerate aspirin and/or hydroclopidogrel or have a history of neutropenia or thrombocytopenia or severe liver dysfunction with clopidogrel disabled; 27. Subjects that are intolerant or allergic to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid polymers, stainless steel, etc.; 28. Have leukopenia (white blood cell count <3*10 9/L more than 3 days) or have neutropenia (ANC<1000 neutrophils/mm3 more than 3 days) or have a history of thrombocytopenia (<100,000 platelets/mm3) Subject; 29. Subjects with a history of peptic ulcer or gastrointestinal bleeding over the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac events;Clinical symptom-driven target lesion revascularization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Interventional therapy success rate; | — |
Countries
China
Contacts
Public ContactGuosheng Fu
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed