A Multicenter, Prospective, Open-label, Controlled, Randomized Trial of Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,860
- 试验地点
- 18
- 主要终点
- Target lesion failure (TLF)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
DCB treatment
Non-flow limited vulnerable plaque will be treated by drug-coated balloon when the enrolled individual is randomized into DCB treatment group. The individual located in DCB treatment will receive guideline-directed medical treatment.
干预措施: Drug-coated balloon (Device)
DCB treatment
Non-flow limited vulnerable plaque will be treated by drug-coated balloon when the enrolled individual is randomized into DCB treatment group. The individual located in DCB treatment will receive guideline-directed medical treatment.
干预措施: Guideline-directed medical treatment (Drug)
Guideline-directed medical treatment
Non-flow limited vulnerable plaque will be left with no intervention when the individual is randomized into guideline-directed medical treatment group. The individual will receive guideline-directed medical treatment alone.
干预措施: Guideline-directed medical treatment (Drug)
结局指标
主要结局
Target lesion failure (TLF)
时间窗: At 24 months
次要结局
- Plaque burden after DCB treatment(At baseline)
- Cardiac death and target lesion MI(At 24 months)
- Minimal lumen area after DCB treatment(At baseline)
- PB >70% after DCB treatment(At baseline)
- Target lesion failure (TLF)(At 12 months)
- Major cardiac adverse event (MACE)(At 24 months)
- All-cause death(At 24 months)
- Cardiac death(At 24 months)
- Target lesion myocardial infarction(At 24 months)
- Periprocedural myocardial infarction(At 24 months)
- Periprocedural and non-periprocedural myocardial infarction(At 24 months)
- Target vessel failure (TVF)(At 24 months)
- FCT after DCB treatment(At baseline)
- PB >65% after DCB treatment(At baseline)
- Lipid arc after DCB treatment(At baseline)
- FCT <75 μm after DCB treatment(At baseline)
- MLA <3.5 mm^2 after DCB treatment(At baseline)
- Maximal lipid arc >180° after DCB treatment(At baseline)
- Cardiac biomarkers: GDF-15, interleukin-6, interleukin-1β and ceramide etc.(At baseline and one-year follow-up)
研究者
Yu Bo
Director, Cardiology Department, the 2nd Affiliated Hospital of Harbin Medical University
Harbin Medical University