Acute Coronary Syndrome (ACS)
Conditions
Brief summary
The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome.
Interventions
DEVICEDrug-coated balloon
Non-culprit lesion will be pretreated before DCB treatment. The bail-out stent treatment is permitted if pretreatment failed.
All individuals will receive guideline-directed medical treatment.
Sponsors
Shanghai Shenqi Medical Technology Co., Ltd
Harbin Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects must be between 18 and 80 years of age 2. Subject must present with acute myocardial infarction or unstable angina planned for PCI 3. Successful stent implantation (i.e., residual stenosis less than 20%) must be done in culprit lesions and any lesions with ischemia evidence (e.g., QFR equal or less than 0.8) 4. Subject must have at least one native non-culprit lesion with visually estimated stenosis of 40-80% and QFR \>0.8 5. Target lesion must have a visually estimated diameter of 2.0-4.0 mm and length of ≤ 50 mm 6. Target lesion must have any two of the intravascular imaging criteria of PB \>65%, MLA \<3.5 mm\^2 (OCT) or 4.0mm\^2 (IVUS), FCT \<75 μm, or maximal lipid arc \>180° 7. Subject must provide written informed consent before any study-related procedure
Exclusion criteria
1. Subject has known hypersensitivity or contraindication to any of the study drugs (including all asprin, P2Y12 inhibitors, one or more components of the study devices, including paclitaxel, etc) that cannot be adequately pre-medicated 2. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.) 3. Hypotension, shock, or need for mechanical support or intravenous vasopressors; 4. Creatinine clearance ≤30 ml/min/1.73 m\^2 (as calculated by MDRD formula for estimated GFR) 5. Left ventricular ejection fraction\<30% by the most recent imaging test within 30 days before procedure (echo, MRI, contrast left ventriculography or others) 6. Life expectancy \<2 years for any 7. Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint 8. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 9. The target lesion is located within 10 mm of the proximal or distal of stent 10. The target lesion cannot be in the left main coronary artery 11. The target lesion is located in a bifurcation lesion (i.e., the diameter of the branch vessels is \>2 mm with \>50% of stenosis) 12. The target lesion is located in severe calcification or tortuosity of vessels 13. The target lesion involved in the ostium of LAD, LCX or RCA (within 3 mm of the ostium) 14. The target lesion is located within the bypass graft artery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion failure (TLF) | At 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major cardiac adverse event (MACE) | At 30 days | MACE is defined as the composite of all-cause death, recurrent myocardial infarction, revascularization, unplanned readmission for angina exacerbation or unstable angina |
| All-cause death | At 30 days | Any death will be recorded as all-cause death |
| Cardiac death and target lesion MI | At 30 days | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment |
| Cardiac death | At 30 days | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Cardiac death is defined as any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment |
| Target lesion myocardial infarction | At 30 days | Target lesion Myocardial Infarction (TL-MI) and non-TL-MI will be assessed |
| Periprocedural myocardial infarction | At 30 days | Periprocedural Myocardial Infarction (TL-MI) and non-Periprocedural will be assessed. |
| Periprocedural and non-periprocedural myocardial infarction | At 30 days | Periprocedural Myocardial Infarction (TL-MI) and non-periprocedural will be assessed |
| Target vessel failure (TVF) | At 30 days | TVF is defined as the composite of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization. |
| Minimal lumen area after DCB treatment | At baseline | Post-procedure imaging examination is required |
| Target lesion failure (TLF) | At 30 days | — |
| FCT after DCB treatment | At baseline | Post-procedure imaging examination is required |
| Lipid arc after DCB treatment | At baseline | Post-procedure imaging examination is required |
| FCT <75 μm after DCB treatment | At baseline | Post-procedure imaging examination is required |
| PB >65% after DCB treatment | At baseline | Post-procedure imaging examination is required |
| PB >70% after DCB treatment | At baseline | Post-procedure imaging examination is required |
| MLA <3.5 mm^2 after DCB treatment | At baseline | Post-procedure imaging examination is required |
| Maximal lipid arc >180° after DCB treatment | At baseline | Post-procedure imaging examination is required |
| Cardiac biomarkers: GDF-15, interleukin-6, interleukin-1β and ceramide etc. | At baseline and one-year follow-up | The centers with sample preservation qualifications will be asked to preserve blood samples. |
| Plaque burden after DCB treatment | At baseline | Post-procedure imaging examination is required |
Countries
China
Contacts
Primary ContactHaibo Jia, PhD
Outcome results
None listed