About this trial
This study aims to investigate and compare the local inflammatory responses and plaque healing characteristics between sirolimus-coated and paclitaxel-coated coronary drug-coated balloons in patients with acute coronary syndrome.
Eligibility criteria
Qualifiers
Age between 18 and 80 years old, both genders eligible;
Coronary angiography showing non-complex lesions with acute coronary syndrome (non-ST-elevation myocardial infarction and unstable angina) deemed suitable for drug-coated balloon treatment by the investigator;
Visually estimated lesion length ≤28mm, visually estimated vessel diameter ≥2.5mm and ≤3.0mm;
Successful lesion pre-dilation (must simultaneously meet all 3 criteria: no Type C or greater dissection; TIMI flow grade 3; visually estimated residual stenosis ≤30%);
Disqualifiers
Total occlusion (TIMI 0 flow) lesion;
In-stent restenosis lesion;
Concurrent left main disease or severe three-vessel disease requiring coronary artery bypass grafting;
Target lesion with severe calcification or tortuosity that cannot be crossed by guidewire;
Trial design
Treatments tested in this trial
- Sirolimus-coated DCB
- Paclitaxel-coated DCB