Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment (NCT07514988) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment
China60 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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;
✓. 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%);
✓. Able to understand the study purpose, willing to complete follow-up visits, and voluntarily provide informed consent.
Exclusion criteria
✕. 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;
✕. Coronary artery bypass graft stenosis;
✕. Confirmed ST-elevation myocardial infarction;
✕. Cardiogenic shock or requiring mechanical respiratory and circulatory support;
What they're measuring
1
Optical coherence tomography assessment of target lesion healing and repair at 3-month follow-up after the procedure
Timeframe: 3 months
Trial details
NCT IDNCT07514988
SponsorChina National Center for Cardiovascular Diseases