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OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter cohort study aims to assess the efficacy and safety of OCT- versus angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery after lesion preparation with scoring balloon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCT-guided arm | Active Comparator |
| |
| Angiography-guided arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT-guided paclitaxel drug-coated balloon angioplasty | Device | OCT-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late lumen loss | Evaluated by QCA | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of binary restenosis | Evaluated by QCA | 9 months |
| Target lesion failure | Including death, target vessel myocardial infarction, or target lesion revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shao-Ping Nie, MD, PhD | Contact | 86-10-84005256 | spnie@ccmu.edu.cn | |
| Yaping Zeng, MD | Contact | 86-10-84005255 | zengyaping2@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | 100029 | China |
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| Angiography-guided paclitaxel drug-coated balloon angioplasty | Device | Angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery |
|
| 9 months |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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