IVUS-Guided Sirolimus-Coated Balloon Versus Sirolimus-Eluting Stent for De Novo Large Vessel Lesions in ACS: A Non-Inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- In-Segment Late Lumen Loss at 9 Months
研究概览
简要总结
The goal of this interventional study is to evaluate the efficacy and safety of an intravascular ultrasound (IVUS)-guided sirolimus-coated balloon (SCB)-based strategy versus planned sirolimus-eluting stent (SES) implantation in patients with acute coronary syndrome (ACS) and de novo large-vessel coronary lesions. The main question is whether the SCB-based strategy is non-inferior to the SES strategy with respect to in-segment late lumen loss (LLL) at 9 months. Following adequate lesion preparation and confirmation according to the prespecified angiographic and IVUS criteria that the target lesion is suitable for both randomized treatment strategies, participants will be randomly assigned to undergo either SCB treatment without routine stent implantation or planned SES implantation. In the SCB group, bail-out SES implantation will be performed when clinically necessary, such as in cases of significant residual stenosis or flow-limiting dissection. Participants will undergo angiographic and IVUS follow-up at 9 months, and clinical outcomes will be assessed through 12 months.
详细描述
Lesion preparation will be performed before randomization. Individuals with unsuccessful lesion preparation will be considered pre-randomization failures and will not be assigned to either study arm. The reason for unsuccessful lesion preparation, the treatment subsequently received, and limited safety information through 48 hours after the procedure will be documented for screening and safety oversight purposes only. These individuals will not undergo protocol-mandated follow-up and will not be included in the efficacy or comparative safety analyses of the randomized trial.
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)
盲法说明
Participants and treating physicians are not masked. Clinical endpoints are adjudicated by an independent Clinical Events Committee blinded to treatment allocation. The statistical team will remain blinded to coded treatment groups until database lock. Angiographic and IVUS assessments will be performed by an independent core laboratory; however, complete masking of the core laboratory is not feasible because stent implantation is visible on the images.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All of the following criteria must be met:
- •Aged ≥18 years.
- •Diagnosed with acute coronary syndrome (ACS), including unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), or ST-segment elevation myocardial infarction (STEMI). The diagnosis, classification, and clinical management of ACS will follow the 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes. NSTEMI and STEMI will be diagnosed according to the Fourth Universal Definition of Myocardial Infarction.
- •A de novo lesion in a large native coronary artery with a target lesion reference vessel diameter ≥2.75 mm.
- •Only one target lesion is considered to require intervention and is suitable for treatment with a sirolimus-coated balloon (SCB), with bail-out stenting if necessary, or with a sirolimus-eluting stent (SES).
- •Successful lesion preparation according to the prespecified angiographic and IVUS criteria, confirming that the target lesion is suitable for both randomized treatment strategies.
- •The participant has fully understood the study and provided written informed consent.
排除标准
- •Participants meeting any of the following criteria will be excluded:
- •Acute heart failure, acute cardiogenic shock, or persistent hemodynamic instability.
- •Percutaneous coronary intervention within the previous 12 months, including stent implantation, balloon angioplasty, or SCB treatment.
- •A bifurcation lesion requiring simultaneous intervention of both the main vessel and side branch.
- •In-stent restenosis in the target vessel; only de novo lesions are eligible for this study.
- •Lesion anatomy unsuitable for SCB treatment or conventional SES implantation, including:
- •i. Lesion length >40 mm.
- •ii. Chronic total occlusion (CTO).
- •iii. A left main coronary artery target lesion or severe left main coronary artery disease requiring simultaneous treatment.
- •iv. Severe calcification expected to preclude satisfactory lesion preparation.
- •v. Severe vessel tortuosity or angulation >90° that may prevent safe device delivery.
- •vi. A bypass graft lesion or myocardial bridging involving the target lesion.
- •f. Severe hepatic or renal impairment.
- •g. A concomitant condition associated with a life expectancy of less than 1 year.
- •h. Previous coronary artery bypass grafting (CABG).
- •i. Unsuitable for percutaneous coronary intervention or long-term antithrombotic therapy, including:
- •Known contraindication to aspirin, heparin, antiplatelet agents, or contrast media.
- •A history of intracranial hemorrhage. Pregnancy, breastfeeding, or planned pregnancy during the study period.
- •j. Previous prosthetic heart valve replacement.
- •k. Participation in another clinical study or clinical trial within the previous 12 months.
- •l. Known severe hypersensitivity to sirolimus or its derivatives, any component of the study devices-including the SES polymer or metal-or contrast media; or inability or unwillingness to undergo repeat coronary angiography and IVUS at 9 months for any other reason.
- •m. Considered unsuitable for enrollment by the investigator because of anticipated nonadherence or any other reason.
研究组 & 干预措施
IVUS-Guided Sirolimus-Coated Balloon
Following successful lesion preparation, the sirolimus-coated balloon will be used for drug delivery without routine stent implantation. Bail-out sirolimus-eluting stent implantation will be performed in cases of significant residual stenosis, flow-limiting dissection, impaired coronary flow, or other prespecified indications. Participants requiring bail-out stenting will remain in the SCB group and will be analyzed according to their randomized treatment strategy.
干预措施: IVUS-Guided Sirolimus-Coated Balloon (Device)
IVUS-Guided Sirolimus-Eluting Stent
Following successful lesion preparation, planned sirolimus-eluting stent implantation will be performed under IVUS guidance to optimize stent expansion and apposition.
干预措施: IVUS-Guided Sirolimus-Eluting Stent (Device)
结局指标
主要结局
In-Segment Late Lumen Loss at 9 Months
时间窗: 9 months
In-segment late lumen loss (LLL) of the target lesion is calculated as the in-segment minimal lumen diameter (MLD) measured immediately after the index procedure minus the in-segment MLD measured at 9-month follow-up, assessed by quantitative coronary angiography (QCA) by an independent angiographic core laboratory. The in-segment analysis region comprises the device-treated segment plus the 5 mm proximal and 5 mm distal edge segments. A negative value indicates lumen enlargement relative to the immediate post-procedural result. The mean value will be reported.
次要结局
- Periprocedural Complications(Within 48 hours after the procedure)
- Target Lesion Failure (TLF)(12 months)
- Patient-oriented Composite Endpoint (PoCE)(12 months)
- Bleeding Events(12 months)
- Net Adverse Clinical Events (NACE)(12 months)
- IVUS-derived External Elastic Membrane area(Pre-procedure, immediately post-procedure, and 9 months)
- IVUS-derived minimum lumen area(Pre-procedure, immediately post-procedure, and 9 months)
- IVUS-derived plaque burden(Pre-procedure, immediately post-procedure, and 9 months)
- Minimum lumen diameter(Pre-procedure, immediately post-procedure, and 9 months)
- Percent diameter stenosis(Pre-procedure, immediately post-procedure, and 9 months)
- Binary restenosis(9 months)
- Acute lumen gain(Immediately post-procedure)
- Net lumen gain(9 months)
- Late lumen enlargement(9 months)
- Length of Index Hospital Stay(From admission to discharge for the index hospitalization)
- Percentage of Participants With Cardiovascular-Related Rehospitalization(12 months)
- Percentage of Participants With Repeat Coronary Revascularization(12 months)
- Cumulative Cardiovascular-Related Direct Medical Costs(12 months)
研究者
Erli Zhang
Principal Investigator
Chinese Academy of Medical Sciences, Fuwai Hospital