The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world. The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm.
Study Design: 1. Prospective, international multi-center clinical study; 2. It is planned to recruit 300 subjects in China and a total of 100 subjects in Indonesia and Thailand who meet the criteria for study inclusion to use at least one Biolimus coated coronary balloon dilation catheter (BioAscend) to treat primary in situ coronary artery vascular disease with a diameter of 2.0mm-2.75mm regardless of the number of blood vessels, the length and number of treated lesions; 3. In the study, subgroups of long lesions, bifurcation lesions, and acute myocardial infarction were set up, and subjects who met the definition were directly entered into the subgroup analysis. 4. Register and collect data using the EDC system; 5. Enrollment method: competitive enrollment; 6. Follow-up time points: postoperative to before discharge, 30 days, 6 months, 12 months, and 24 months.
Study Type
OBSERVATIONAL
Enrollment
400
Patients with Coronary Artery Disease will be treated with Biolimus Coated Coronary Artery Balloon Dilation Catheter
Target lesion failure rate (TLF)
Target lesion failure rate (TLF) at 12 months after surgery, including cardiogenic death, target vascular myocardial infarction, and clinically symptom-driven target lesion revascularization (CD-TLR)
Time frame: 12 months after surgery
Interventional success rate
Including device success rate, pathogenic power and clinical success rate
Time frame: Immediately after operation
Device-related cardiovascular clinical composite endpoint
Device-related cardiovascular clinical composite endpoints from postoperative to pre-discharge, day 30, month 6, month 12, and month 24, including cardiac death, target vessel myocardial infarction, and clinically symptom-driven target lesion revascularization (excluding elective interventional therapy)Device-related cardiovascular clinical composite endpoints from postoperative to pre-discharge, day 30, month 6, month 12, and month 24, including cardiac death, target vessel myocardial infarction, and clinically symptom-driven target lesion revascularization (excluding elective interventional therapy)
Time frame: From postoperative to before discharge, day 30, month 6, month 12, month 24
Patient-related cardiovascular clinical composite endpoint
Patient-related cardiovascular clinical composite endpoints including all-cause mortality, all myocardial infarction, and any revascularization (excluding elective interventional therapy) from postoperative to pre-discharge, day 30, month 6, month 12, and month 24
Time frame: From postoperative to before discharge, day 30, month 6, month 12, month 24
Major adverse cardiac events (MACEs)
Including cardiac death, myocardial infarction, and target lesion revascularization (TLR) at postoperative to pre-discharge, day 30, month 6, month 12, and month 24.
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Time frame: From postoperative to before discharge, day 30, month 6, month 12, month 24
Incidence of thrombotic events as defined by ARC
Including identified, probable, and unexcluded thrombosis in the acute, subacute, and late periods acute, subacute, and late Defined, probable, and non-excluded thrombosis within the segment
Time frame: From postoperative to before discharge, day 30, month 6, month 12, month 24