Acute Coronary Syndromes (ACS)
Conditions
Brief 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.
Detailed description
This prospective, single-center, randomized, controlled trial aims to evaluate and compare the differential effects of sirolimus-coated versus paclitaxel-coated drug-coated balloons (DCBs) on local inflammatory responses and plaque healing characteristics in patients with acute coronary syndrome (ACS) with optical coherence tomography (OCT).
Interventions
DEVICESirolimus-coated DCB
Treatment of sirolimus-coated DCB
DEVICEPaclitaxel-coated DCB
Treatment of paclitaxel-coated DCB
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OCT-measured minimum lumen area change at 3 months post-procedure | 3 months | 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 | 3 months | 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 | 3 months | 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 | 3 months | Change in macrophage infiltration presence and characteristics assessed by optical coherence tomography from baseline to 3 months post-procedure. |
| OCT-measured thin-cap fibroatheroma count change at 3 months post-procedure | 3 months | Change in number of thin-cap fibroatheroma (TCFA) lesions measured by optical coherence tomography from baseline to 3 months post-procedure. TCFA defined as lipid-rich plaque with fibrous cap thickness \<65μm. Unit: count. |
| OCT-measured lipid pool length change at 3 months post-procedure | 3 months | Change in lipid pool length measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: mm. |
| OCT assessment of microchannel change at 3 months post-procedure | 3 months | Change in microchannel presence and characteristics assessed by optical coherence tomography from baseline to 3 months post-procedure. |
| OCT-measured minimum lumen diameter change at 3 months post-procedure | 3 months | Change in minimum lumen diameter measured by optical coherence tomography from baseline to 3 months post-procedure. Unit: mm. |
| CCTA-measured perivascular fat attenuation index change at 6 months | 6 months | Change in perivascular fat attenuation index (FAI) measured by coronary computed tomography angiography from baseline to 6 months post-procedure. FAI is defined as the mean CT attenuation value of perivascular adipose tissue surrounding the coronary artery. Unit: Hounsfield Units (HU). |
| CCTA-measured low-attenuation plaque volume change at 6 months post-procedure | 6 months | Change in low-attenuation plaque volume measured by coronary computed tomography angiography from baseline to 6 months post-procedure. Low-attenuation plaque is defined as plaque with CT value \<30 HU. Unit: mm³. |
| CCTA-measured plaque burden change at 6 months post-procedure | 6 months | Change in plaque burden measured by coronary computed tomography angiography from baseline to 6 months post-procedure. Plaque burden is calculated as plaque volume divided by total vessel volume multiplied by 100%. Unit: percentage (%). |
| Incidence of target lesion failure (TLF) at 6 months post-procedure | 6 months | Target lesion failure (TLF) was defined as a composite endpoint consisting of cardiovascular death, target vessel-related myocardial infarction, and clinically-driven target lesion revascularization. |
| Incidence of patient-oriented composite endpoint (PoCE) at 6 months post-procedure | 6 months | Patient-oriented composite endpoint (PoCE) was defined as a composite of all-cause death, any stroke, any myocardial infarction, and any revascularization. |
Countries
China
Contacts
CONTACTJie Zhao, MD, PhD
PRINCIPAL_INVESTIGATORJie Zhao, MD, PhD
Chinese Academy of Medical Sciences, Fuwai Hospital
Outcome results
None listed