Sirolimus-coated DCB: Treatment of sirolimus-coated DCB
Paclitaxel-coated DCB: Treatment of paclitaxel-coated DCB
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
Subjects must meet all of the following criteria to be enrolled:
1. Age between 18 and 80 years old, both genders eligible;
2. 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;
3. Visually estimated lesion length ≤28mm, visually estimated vessel diameter ≥2.5mm and ≤3.0mm;
4. 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%);
5. Able to understand the study purpose, willing to complete follow-up visits, and voluntarily provide informed consent.
Exclusion Criteria:
Subjects will be excluded if they meet any of the following criteria:
1. Total occlusion (TIMI 0 flow) lesion;
2. In-stent restenosis lesion;
3. Concurrent left main disease or severe three-vessel disease requiring coronary artery bypass grafting;
4. Target lesion with severe calcification or tortuosity that cannot be crossed by guidewire;
5. Coronary artery bypass graft stenosis;
6. Confirmed ST-elevation myocardial infarction;
7. Cardiogenic shock or requiring mechanical respiratory and circulatory support;
8. Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
9. Severe renal insufficiency or undergoing hemodialysis;
10. Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media, paclitaxel, sirolimus and/or other analogues;
11. Systemic lupus erythematosus or other systemic autoimmune diseases;
12. History of stroke within 6 months prior to enrollment;
13. Scheduled elective surgery within 6 months after enrollment requiring discontinuation of anticoagulant or antiplatelet medications;
14. Currently participating in other drug or interventional medical device clinical studies;
15. Other conditions deemed unsuitable for enrollment by the investigator.
Primary outcome measure(s)
Optical coherence tomography assessment of target lesion healing and repair at 3-month follow-up after the procedure — 3 months 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.
Trial sites (1)
Facility
City
Region
Status
Fuwai hospital, CAMS&PUMC
Beijing
Beijing Municipality
More China National Center for Cardiovascular Diseases trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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