Using drug-coated balloons to treat vulnerable atherosclerotic plaques in heart patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, open-label, controlled, randomized trial aims to compare the effectiveness of drug-coated balloon (DCB) treatment against guideline-directed medical therapy (GDMT) for patients with acute coronary syndrome (ACS). The study focuses on patients who have non-flow limited vulnerable plaques and seeks to demonstrate that DCB treatment can lead to better clinical cardiovascular outcomes. Participants will undergo procedures involving successful stent implantation and will be monitored for improvements in their condition. The trial will include various medical centers to ensure a diverse patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• The Second Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Recruiting
• Affiliated Beijing Luhe Hospital of Capital Medical University
  Beijin, Beijing Municipality, China Not yet recruiting
• Affiliated Hospital of Zunyi Medical University
  Zunyi, Guizhou, China Not yet recruiting
• Daqing Oilfield General Hospital
  Daqing, Heilongjiang, China Not yet recruiting
• The First Affiliated Hospital of Jiamusi University
  Jiamusi, Heilongjiang, China Not yet recruiting
• Mudanjiang Cardiovascular Hospital
  Mudanjiang, Heilongjiang, China Not yet recruiting

Study contacts

• Principal investigator: Bo Yu, PhD — The Second Affiliated Hospital of Harbin Medical University
• Study coordinator: Haibo Jia, PhD
• Email: jhb101180@163.com
• Phone: 15945685291

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.