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The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly coronary arteries.
And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCB Group | Experimental | Implantation of drug-coated balloons in patients with satisfactory pretreatment |
|
| DES Group | Experimental | Implantation of drug-eluting stents in patients with satisfactory pretreatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DES | Device | Second-generation drug-eluting stents |
| |
| DCB |
| Measure | Description | Time Frame |
|---|---|---|
| LLL | Late lumen loss (LLL) of the target lesion segment | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | Cardiovascular death, target vessel revascularization, target vessel non-lethal myocardial infarction | Perioperative period, 30 days, 3 months, 6 months, 12 months after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muwei Li, MD | Fuwai central China cardiovascular hospotial | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai central China cardiovascular Hospital | Zhengzhou | Henan | China |
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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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| Device |
Drug-coated balloon with paclitaxel as drug coating |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |