Drug-coated balloonGuideline-directed medical treatment
Drug-coated balloon: Non-culprit lesion will be pretreated before DCB treatment. The bail-out stent treatment is permitted if pretreatment failed.
Guideline-directed medical treatment: All individuals will receive guideline-directed medical treatment.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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
Primary outcome measure(s)
Target lesion failure (TLF) — At 24 months
Trial sites (18)
Facility
City
Region
Status
Affiliated Beijing Luhe Hospital of Capital Medical University
Beijin
Beijing Municipality
Not Yet Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi
Guizhou
Not Yet Recruiting
Daqing Oilfield General Hospital
Daqing
Heilongjiang
Not Yet Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin
Heilongjiang
Recruiting
The First Affiliated Hospital of Jiamusi University
Jiamusi
Heilongjiang
Not Yet Recruiting
Mudanjiang Cardiovascular Hospital
Mudanjiang
Heilongjiang
Not Yet Recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou
Henan
Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Not Yet Recruiting
Tongji Hospital Tongji Medical College of HUST
Wuhan
Hubei
Not Yet Recruiting
The Third Second Hospital of Jilin University
Changchun
Jilin
Not Yet Recruiting
Dalian Municipal Central Hospital
Dalian
Liaoning
Not Yet Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian
Liaoning
Not Yet Recruiting
The People's Hospital of Liaoning Province
Shengyang
Liaoning
Not Yet Recruiting
The Affiliated Hospital of Neimenggu Medical University
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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