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This was a single-center, prospective, open-label, observational study. Patients with coronary artery disease confirmed by coronary angiography and treated with drug-coated balloon catheter alone for target vessels were enrolled in the Cardiology Department of our hospital in January 2022. The primary endpoint was late lumen loss within 12±3 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| De novo coronary lesions: cutting balloon group | De novo coronary lesions were pretreated with a cutting balloon and then treated with a drug-coated balloon. |
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| De novo coronary lesions: non-cutting balloon group | De novo coronary lesions were pretreated with a non-cutting (Compliance balloon or/and non-compliant balloon) balloon and then treated with a drug-coated balloon. |
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| In-stent restenosis: Type-I | Body stenosis: restenosis of the stent body, not beyond the edge of the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons. |
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| In-stent restenosis: Type-II | Marginal stenosis type: restenosis at the edge of the stent, stenosis ≥50% within 5mm of the stent edge, which can continue into the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons. |
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| In-stent restenosis:Type-III | Diffuse proliferative type: the lesion extends to the whole scaffold body and beyond the edge of both ends.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pretreatment strategies before drug balloon therapy | Procedure | Preconditioning strategies for the treatment of in de novo coronary lesions using drug-coated balloons. |
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| Measure | Description | Time Frame |
|---|---|---|
| LLL of 12±3 months after surgery | Late lumen loss of 12±3 months after surgery | 12±3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| MACE event 12 months after surgery | The incidence of MACE events (target vessel revascularization, target vessel myocardial infarction, cardiac death) at 12 months after surgery. | 12 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with coronary heart disease by coronary angiography and treated with DCB alone in the Department of Cardiology of our hospital since January 2022 were included in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| In-stent restenosis:Type-IV | Complete occlusion type: complete occlusion in the stent.The lesions were pretreated with balloon dilation and then treated with drug-coated balloons. |
|
| Different types of in-stent restenosis were treated with drug-coated balloons | Procedure | A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon. |
|
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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