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.
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%);
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;
Parallel
Sirolimus-coated DCB
DeviceTreatment of sirolimus-coated DCB
Paclitaxel-coated DCB
DeviceTreatment of paclitaxel-coated DCB
Optical coherence tomography assessment of target lesion healing and repair at 3-month follow-up after the procedure
OCT assessment of target lesion healing based on three morphological criteria: fibrous cap thickness (FCT), maximum lipid arc, and macrophage infiltration. Target lesion is defined as unhealed if any of the following criteria are met: (1) FCT \<75μm, (2) maximum lipid arc \>180°, or (3) presence of macrophage infiltration. Target lesion is defined as healed only if all three criteria are met: (1) FCT ≥75μm; (2) maximum lipid arc ≤180°; (3) absence of macrophage infiltration. The primary outcome is reported as the proportion of patients with healed target lesions.
OCT-measured minimum lumen area change at 3 months post-procedure
Change in minimum lumen area (MLA) measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: mm².
OCT-measured fibrous cap thickness change at 3 months post-procedure
Change in fibrous cap thickness (FCT) measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: μm.
OCT-measured maximum lipid arc change at 3 months post-procedure
Change in maximum lipid arc measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: degrees.
OCT assessment of macrophage infiltration change at 3 months post-procedure
Change in macrophage infiltration presence and characteristics assessed by optical coherence tomography from baseline to 3 months post-procedure.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
