Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment
Starting soon · Not applicable
Conditions studied: Acute Coronary Syndromes (ACS)
In brief
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.
Key facts
- Study ID
- NCT07514988
- Run by
- China National Center for Cardiovascular Diseases
- People needed
- 60
- Starts
- 2026-05-01
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-04-07
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects must meet all of the following criteria to be enrolled:
- 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%);
- Able to understand the study purpose, willing to complete follow-up visits, and voluntarily provide informed consent.
You may not qualify if…
- Subjects will be excluded if they meet any of the following 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;
- Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
- Severe renal insufficiency or undergoing hemodialysis;
- Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media, paclitaxel, sirolimus and/or other analogues;
- Systemic lupus erythematosus or other systemic autoimmune diseases;
- History of stroke within 6 months prior to enrollment;
- Scheduled elective surgery within 6 months after enrollment requiring discontinuation of anticoagulant or antiplatelet medications;
- Currently participating in other drug or interventional medical device clinical studies;
- Other conditions deemed unsuitable for enrollment by the investigator.
Where it is running
- Fuwai hospital, CAMS&PUMC — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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