Coronary artery disease
Conditions
Interventions
Test group:Paclitaxel-Eluting Balloon Catheter
Control group:Drug-coated stent
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18-80 years old (inclusive of 18 and 80 years old); (2) Patients with evidence of asymptomatic ischemia, stable or unstable angina pectoris, or subjects with old myocardial infarction; (3) Subjects who are capable of undergoing coronary artery bypass surgery (coronary artery bypass grafting) treatment; (4) Subjects who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to undergo invasive imaging follow-up; (5) The target lesion is a primary and in situ coronary artery lesion located on one or two different coronary arteries, with no more than one target lesion on each coronary artery. (6) The degree of stenosis in the diameter of the target lesion is =70% and < 100% or =50%, accompanied by evidence of local ischemia (visual inspection); (7) The length of the target lesion is =36mm; The diameter of the target lesion blood vessel is between 2.5mm and 4.0mm (visually estimated); (8) If non-target lesions exist simultaneously, interventional treatment must be carried out first and the treatment must be successful before random grouping can be conducted. (9) Each target lesion can be completely covered by one test instrument, and control instruments can be used in combination.
Exclusion criteria
Exclusion criteria: (1) Those who have suffered myocardial infarction within one month; (2) Subjects with severe congestive heart failure (LVEF 443umol/L) or those undergoing hemodialysis treatment; Patients with abnormal liver function (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 120U/L); (8) Hematological system abnormalities: Leukopenia (WBC 30% or TIMI blood flow < grade 3 after pre-dilation of the target lesion, and/or dissection of type C or above occurs after pre-dilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lumen loss (LLL) within the target lesion segment 9 months after the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of intra-segment diameter stenosis degree of the target lesion (DS%) 9 months after the operation;Successful interventional therapy (including successful devices, successful lesions, and clinical success);Clinical symptom-driven target lesion revascularization (CD-TLR) at 1 month, 6 months, 9 months and 12 months after the operation;One month, six months, nine months and twelve months after the operation, the device-related cardiovascular composite endpoint (DoCE), namely target lesion failure (TLF), includes cardiogenic death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization (CD-TLR).;The combined cardiovascular endpoint (PoCE) related to the subjects was 1 month, 6 months, 9 months and 12 months after the operation, including all-cause death, all myocardial infarctions and any re-revascularization;Evaluation of device performance; | — |
Countries
China
Contacts
Public ContactGe Junbo
Zhongshan Hospital Fudan University
Outcome results
None listed