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

A Multicenter, Prospective, Open-label, Controlled, Randomized Trial of Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)

This study is testing if a special balloon treatment can help heart patients with risky plaque in their arteries feel better compared to standard medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1860 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Harbin Medical University (Academic / other)
• Locations: 18 sites (Beijin, Beijing Municipality and 17 other locations)
• Trial ID: NCT06365502 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have experienced acute myocardial infarction or unstable angina and have specific criteria related to their coronary lesions.

Not a fit: Patients with known hypersensitivity to study drugs or contraindications to the study devices may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could significantly improve cardiovascular outcomes for patients with vulnerable atherosclerotic plaques.

How similar studies have performed: Other studies have shown promising results with drug-coated balloons in similar contexts, suggesting potential for success in this approach.

Eligibility criteria

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 this trial is running

Beijin, Beijing Municipality and 17 other locations

• 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 Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
• The First Affiliated Hospital of Jiamusi University — Jiamusi, Heilongjiang, China (Not_yet_recruiting)
• Mudanjiang Cardiovascular Hospital — Mudanjiang, Heilongjiang, China (Not_yet_recruiting)
• Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Tongji Hospital Tongji Medical College of HUST — Wuhan, Hubei, China (Not_yet_recruiting)
• The Third Second Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Dalian Municipal Central Hospital — Dalian, Liaoning, China (Not_yet_recruiting)
• The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Not_yet_recruiting)
• The People's Hospital of Liaoning Province — Shengyang, Liaoning, China (Not_yet_recruiting)
• The Affiliated Hospital of Neimenggu Medical University — Hohhot, Neimenggu, China (Not_yet_recruiting)
• Shandong Provincial Hospital — Jinan, Shandong, China (Not_yet_recruiting)
• Affiliated Hospital of Jining Medical University — Jining, Shandong, China (Not_yet_recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Not_yet_recruiting)
• Yantai Yuhuangding Hospital — Yantai, Shandong, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Bo Yu, PhD — The Second Affiliated Hospital of Harbin Medical University
• Study coordinator: Haibo Jia, PhD

Conditions Acute Coronary Syndrome