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

Official title

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

Overview

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.

Interventions

• Device Drug-coated balloon
  Non-culprit lesion will be pretreated before DCB treatment. The bail-out stent treatment is permitted if pretreatment failed.
• Drug Guideline-directed medical treatment
  All individuals will receive guideline-directed medical treatment.

Primary outcome measures

• Target lesion failure (TLF) [Time frame: At 24 months]

Secondary outcome measures (12)

• Target lesion failure (TLF) [Time frame: At 30 days]
• Target lesion failure (TLF) [Time frame: At 6 months]
• Target lesion failure (TLF) [Time frame: At 12 months]
• Major cardiac adverse event (MACE) [Time frame: At 30 days]
• Major cardiac adverse event (MACE) [Time frame: At 6 months]
• Major cardiac adverse event (MACE) [Time frame: At 12 months]
• Major cardiac adverse event (MACE) [Time frame: At 24 months]
• All-cause death [Time frame: At 30 days]
• All-cause death [Time frame: At 6 months]
• All-cause death [Time frame: At 12 months]
• All-cause death [Time frame: At 24 months]
• Cardiac death and target lesion MI [Time frame: At 30 days]

Eligibility criteria

Inclusion criteria

• Subjects must be between 18 and 80 years of age
• Subject must present with acute myocardial infarction or unstable angina planned for PCI
• 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)
• Subject must have at least one native non-culprit lesion with visually estimated stenosis of 40-80% and QFR >0.8
• Target lesion must have a visually estimated diameter of 2.0-4.0 mm and length of ≤ 50 mm
• 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°
• Subject must provide written informed consent before any study-related procedure

Exclusion criteria

• 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
• 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.)
• Hypotension, shock, or need for mechanical support or intravenous vasopressors;
• Creatinine clearance ≤30 ml/min/1.73 m\^2 (as calculated by MDRD formula for estimated GFR)
• Left ventricular ejection fraction<30% by the most recent imaging test within 30 days before procedure (echo, MRI, contrast left ventriculography or others)
• Life expectancy <2 years for any
• Subject is currently participating in another investigational drug or device clinical study that has not yet completed its primary endpoint
• 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.
• The target lesion is located within 10 mm of the proximal or distal of stent
• The target lesion cannot be in the left main coronary artery
• The target lesion is located in a bifurcation lesion (i.e., the diameter of the branch vessels is >2 mm with >50% of stenosis)
• The target lesion is located in severe calcification or tortuosity of vessels
• The target lesion involved in the ostium of LAD, LCX or RCA (within 3 mm of the ostium)
• The target lesion is located within the bypass graft artery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 18 centers

• Affiliated Beijing Luhe Hospital of Capital Medical University — Beijin
• Affiliated Hospital of Zunyi Medical University — Zunyi
• Daqing Oilfield General Hospital — Daqing
• The Second Affiliated Hospital of Harbin Medical University — Harbin
• The First Affiliated Hospital of Jiamusi University — Jiamusi
• Mudanjiang Cardiovascular Hospital — Mudanjiang
• Fuwai Central China Cardiovascular Hospital — Zhengzhou
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou
• … and 10 more centers

Identifiers

NCT: NCT06365502 · KY2023-156

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗