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

Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque: an OCT-IVUS Imaging Substudy (RESTORE Imaging)

This study is testing whether a special balloon treatment can better stabilize dangerous heart plaques in patients who have had a stent placed compared to standard medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Harbin Medical University (Academic / other)
• Locations: 1 site (Harbin, Heilongjiang)
• Trial ID: NCT06449274 on ClinicalTrials.gov

What this trial studies

This imaging substudy of the RESTORE trial aims to compare the effectiveness of drug-coated balloon (DCB) treatment against guideline-directed medical therapy (GDMT) in stabilizing vulnerable plaques in patients with acute coronary syndrome. The study will enroll at least 180 participants who have undergone successful stent implantation and have specific criteria for non-culprit lesions. By utilizing advanced imaging techniques, the trial seeks to validate the superiority of DCB treatment in improving plaque stabilization and enlarging luminal dimensions.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 who have experienced acute myocardial infarction or unstable angina and are scheduled for percutaneous coronary intervention.

Not a fit: Patients with known hypersensitivity to study drugs or those who do not meet the specific imaging and lesion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with acute coronary syndrome by enhancing plaque stabilization.

How similar studies have performed: Other studies have shown promise in using drug-coated balloons for similar conditions, indicating a 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

Harbin, Heilongjiang

• The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)

Study contacts

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

Conditions Acute Coronary Syndrome