Coronary Atherosclerotic Heart Disease
Conditions
Interventions
Control group:Non-modified balloon angioplasty strategy
Experimental group:Modified balloon angioplasty strategy
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Need for PCI treatment due to acute or chronic coronary artery syndrome; 3. Target lesion is de novo, i.e. newly developed; 4. Vascular stenosis degree > 70%; 2.0 mm < target vessel diameter < 4.0 mm; 5. Meets the indications for DCB treatment; 6. The lesion is suitable for intravascular imaging assessment; 7. The patient and their family have given informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Combined diseases result in an expected lifespan of less than 2 years; 2. Cardiogenic shock; 3. In-stent restenosis; 4. Ineligible for drug-coated balloons: such as patients allergic to paclitaxel or rapamycin; 5. Patients with contrast agent allergy; 6. Patients with severe mental illness, severe liver or kidney dysfunction, or cerebrovascular accidents; 7. Left main coronary artery lesion; 8. Severe calcification lesion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal Lumen Area;Plaque Burden; | — |
Secondary
| Measure | Time frame |
|---|---|
| Periprocedural elevation of cardiac biomarkers;Incidence of hematoma and dissection;Incidence of hematoma and dissection;ST-T changes on electrocardiogram; | — |
Countries
China
Contacts
Public ContactXingang zhang
The First Affiliated Hospital of China Medical University
Outcome results
None listed