Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)

Launched by HARBIN MEDICAL UNIVERSITY · Apr 10, 2024

Keywords

ClinConnect Summary

The RESTORE Trial is a clinical study aimed at improving heart health for patients with acute coronary syndrome (ACS), which includes serious heart conditions like heart attacks and unstable angina. The trial is comparing a new treatment called drug-coated balloon (DCB) angioplasty to standard medical therapy. This new treatment focuses on specific areas in the arteries that may be at risk for causing heart problems, with the goal of helping patients feel better and reducing future heart issues.

To participate in this trial, patients need to be between 18 and 80 years old and must have experienced a recent heart event that requires a procedure called percutaneous coronary intervention (PCI), where a stent is placed in a blocked artery. They should also have specific types of artery blockages that meet the study’s criteria. If eligible, participants can expect to receive either the new DCB treatment or the usual medical care, and they will be closely monitored throughout the study to see how well the treatments work. It's important that participants understand the study details and provide consent before joining.

Gender

ALL

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