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To evaluate the efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(RVD=2.75~4.0mm).
Patients were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a DES. Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, and 12 months after discharge. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and target lesion revascularization (TLF) at 12 months follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-coated balloon | Experimental | Drug-coated balloon is used to treat coronary artery stenosis lesions and improve myocardial blood flow. |
|
| Sirolimus-Eluting Stent | Active Comparator | Sirolimus-Eluting Stent is treated for coronary artery stenosis lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-Coated Balloon | Device | Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure | A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization | 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | Consisting of device success ( after successful delivery of the study balloon, the visual residual stenosis of the target lesion is less than 50%, TIMI level 3 blood flow ) , Lesion success (defined as the proportion of the target lesions in which the final stenosis is <20% after treatment with any other adjunctive therapy ) , Clinical success ( Defined as no major adverse cardiac events caused by ischemia during the subject's hospitalization). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yansong Li | Contact | 8618221277176 | liyansong021@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yansong Li | Shanghai Songjiang Central Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Sirolimus-Eluting Stent | Device | Sirolimus-Eluting Stent is treated for coronary artery stenosis lesions. |
|
| During the hospital stay, up to 7 days after PCI |
| Target lesion failure | A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization | 1 month, 6months follow-up |
| Patient-oriented composite endpoint | A composite of all-cause mortality, myocardial infarction, and any revascularization | 1 month, 6months,12 months follow-up |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |