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To compare the safety and efficacy of Biolimus drug-coated balloon (DCB) versus drug-eluting stent (DES) in the treatment of de novo coronary artery lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Biolimus-Coated Coronary Balloon Dilatation Catheter |
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| Control Group | Active Comparator | Xinyue Drug-Coated Stent System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biolimus-Coated Coronary Artery Balloon Dilatation Catheter | Device | A total of 774 subjects meeting the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Biolimus-Coated Coronary Artery Balloon Dilatation Catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint | The primary endpoint of target lesion failure (TLF) at 1 year post-operation was defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR). | Day of procedure (treatment day), 7 days post-procedure or discharge day, 30 days post-procedure, 6 months post-procedure, 9 months post-procedure, and 1 year post-procedure. |
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General Inclusion Criteria:
Angiographic Inclusion Criteria:
The target lesions are de novo native coronary artery lesions, located in 1 or 2 different coronary arteries; the number of target lesions in each coronary artery shall not exceed 1 (for two-vessel disease, a maximum of 2 target lesions are permitted).
All target lesions shall meet the following requirements:
①The reference vessel diameter is between 2.25 mm and 4.0 mm, and the lesion length ≤ 30 mm;
② The visual estimated stenosis degree before procedure ≥ 70%, or ≥ 50% with documented ischemic evidence;
③ Successful pre-dilation: defined as no NHLBI type C or higher dissection; TIMI flow grade 3; residual stenosis ≤ 30%.
Each target lesion is only allowed to be treated with one investigational device or control device (except for bailout stent implantation).
If the patient has non-target lesions requiring concurrent intervention, such non-target lesions shall be successfully treated prior to the treatment of target lesions.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Yang Project Manager | Contact | 13366024088 | yang.wang@jwmsgrp.com |
| Name | Affiliation | Role |
|---|---|---|
| Bin Liu | Second Hospital of Jilin University | Principal Investigator |
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| Xinyue Drug-Coated Stent System | Device | A total of 774 eligible subjects who met the inclusion and exclusion criteria were enrolled and assigned to the treatment group of Excrossalâ„¢ Xinyue Drug-Coated Stent System. |
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