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The purpose of this study is to analyze potential factors post paclitaxel drug-coated balloon angioplasty in patients with Denovo large vessels disease. It includes imaging endpoints and clinical event endpoints. Over 5000 patients are expected to be enrolled.
This study is a retrospective analysis that retrospectively reviewed over approximately 5000 patients with de novo-large-vessel disease who underwent paclitaxel drug-coated balloon angioplasty. The study endpoints include cardiovascular adverse events at 1 year (cardiovascular death, cardiovascular events) and coronary angiographic outcomes (primarily late lumen loss, restenosis rate). It primarily focuses on differences in baseline characteristics, lesion features, intracavitary imaging characteristics(Including OCT, IVUS), hemodynamic parameter,and procedural approaches among patients. Over 5000 patients are expected to be enrolled.
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| Measure | Description | Time Frame |
|---|---|---|
| MACE | cardiovascular adverse events:defined as death, Myocardial Infarction (MI, Q waves and non-Q waves), emergent cardiac bypass surgery, or any target lesion revascularization (repeat Percutaneous transluminal coronary angioplasty (PTCA) or Coronary artery bypass grafting (CABG)). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| LLL(late lumen loss) | Detection by QCA technique by subtracting the minimum lumen diameter at review from the minimum lumen diameter in the immediate postoperative period | 12 months |
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Inclusion Criteria:
Age:
18 years and older.
Diagnosis:
Diagnosed with coronary artery disease with native large vessel lesions confirmed by coronary angiography.
Scheduled to receive paclitaxel drug-coated balloon angioplasty.
Patients have been fully informed about the nature and purpose of the study, and have voluntarily agreed to participate, with signed informed consent.
Cardiac function classified as NYHA I-III.
Exclusion Criteria:
Known allergies to paclitaxel or any materials used in angioplasty (e.g., contrast agents).
Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).
Active bleeding or clotting disorders.
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This study targets adults aged 18 and over who have been diagnosed with coronary artery disease featuring native large vessel lesions and are scheduled to undergo paclitaxel drug-coated balloon angioplasty.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quan Guo, MD | Contact | +8615670510031 | xinyiguoquan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Muwei Li, Ph.D | Fuwai central China cardiovascular hospotial | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Central China Cardiovascular Hospital | Recruiting | Zhengzhou | 450003 | 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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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |