NCT06794801尚未招募不适用
An Open-Label, Prospective, Single-Center, Randomized Controlled Trial Evaluating the Safety and Efficacy of Drug-Coated Autoperfusion Balloons Versus Conventional Drug-Coated Balloons Guided by IVUS-OCT Multimodal Imaging for Treating Acute Myocardial Infarction: OPERA-AMI Study
LanZhou University1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2025年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Late lumen loss at 9 months after index PCI
研究概览
简要总结
Trial Goals:
- Evaluation of Mid- to Long-Term Safety and Effectiveness of Drug-Coated Autoperfusion Balloon Dilatation Catheter (DCAB) versus Conventional Drug coated balloon (DCB) in Patients with ST Segment Elevation Myocardial Infarction (STEMI).
- Evaluation of Hybrid IVUS-OCT System for Intraoperative Evaluation of DCAB or Conventional DCB Treatment Safety and Effectiveness for De Novo Lesions During Emergency Percutaneous Coronary Intervention (PCI) in Patients with STEMI.
The primary outcome is late lumen loss (LLL) assessed at 9 months following emergency PCI, measured using quantitative coronary angiography (QCA).
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
- None
盲法说明
Using a core laboratory, an impartial third-party evaluation will be carried out for this study to objectively assess each participant's intravascular imaging and coronary angiography results.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ST-Elevation Myocardial Infarction Meeting PPCI Criteria: 1) Chest pain lasting more than 20 minutes, with ST-segment elevation of at least 1 mm in two or more adjacent leads, new left bundle branch block, or evidence of posterior wall myocardial infarction; 2) Onset of symptoms within 12 hours.
- •Patients Who Have Received Thrombolytic Therapy Within 6 Hours of Symptom Onset and Are Eligible for Rescue PCI Within 24 Hours;
- •Infarct-Related Artery Selection Imaging and Pre-Treatment Criteria Meeting PPCI Standards: 1) De novo lesions. 2) Reference vessel diameter between 2.5 mm and 4 mm. 3) Successful pre-treatment of target lesions: post-pre-treatment residual stenosis of the culprit vessel ≤ 30%, with no type C dissections (or intravascular imaging indicating significant residual plaque burden at the site of dissection, with transverse expansion > 60°, longitudinal expansion > 2 mm, dissection involving the media or adventitia, and located at the distal end of the stent), no hematoma, and no significant thrombus (TIMI thrombus burden grade ≤ 2);
- •Sufficient compliance with the study protocol, agreement to undertake follow-up, and coronary angiography at 9 months;
- •Voluntary Participation in This Study, Including Signing a Written Informed Consent with Understanding of All Risks and Benefits Described in the Informed Consent Document.
排除标准
- •Age < 18 years and > 75 years;
- •History of prior myocardial infarction;
- •Allergy to contrast agent/inability to tolerate contrast;
- •Known contraindications / inability to tolerate bivalirudin, fondaparinux, heparin, aspirin, clopidogrel, and/or ticagrelor;
- •Complex coronary lesions: left main lesions, lesions at the ostia of the left anterior descending or circumflex arteries, lesion length > 30 mm, severe calcification, severe tortuosity or angulation, bifurcation lesions requiring the implantation of more than two drug-coated balloons (DCBs) or drug-eluting stents;
- •In-stent restenosis or in-stent thrombus lesions;
- •Planned simultaneous intervention on non-target lesions;
- •Active bleeding or recent history of bleeding;
- •Uncertain neurological outcomes, such as resuscitation;
- •Intubation / ventilation;
- •Cardiogenic shock prior to randomization;
- •Known intracranial disease (tumors, aneurysms, arteriovenous malformations, hemorrhagic CVA, ischemic CVA/TIA within the last 6 months, including permanent neurological deficits from ischemic cerebrovascular disease) ;
- •Refusal of blood transfusion;
- •Planned major surgery within 6 weeks;
- •Stent implantation < 1 month prior to enrollment;
- •Life expectancy of less than 12 months;
- •Participation in another clinical trial that interferes with this study.
研究组 & 干预措施
Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）
Experimental
3 μg/mm² paclitaxel-coated drug-coated autoperfusion balloon dilatation catheter (DCAB). The DCAB features two radiopaque marker rings at the balloon shoulders for intravascular imaging and positioning, self-perfusion holes on the catheter shaft, and an additional radiopaque marker ring proximal to the perfusion holes to indicate their location. The catheter shaft is hydrophilically coated to facilitate blood flow through the perfusion holes when the guidewire is retracted. Preclinical studies show this design allows 15%-20% of arterial blood to reach the distal coronary artery.
干预措施: Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB） (Device)
Conventional Drug coated ballon（DCB）
Active Comparator
Bingo® PTCA Drug Delivery System: drug (paclitaxel) coated balloon (DCB) with concentration of 3 μg Paclitaxel per 1 mm2.
干预措施: Conventional Drug coated balloon (DCB) (Device)
结局指标
主要结局
Late lumen loss at 9 months after index PCI
时间窗: 9±2 months
Late lumen loss, as assessed by quantitative coronary angiography, at 9 months following the index percutaneous coronary intervention.
次要结局
- The incidence of bailout stenting following DCB implantation(index PCI)
- Minimum lumen area and Lumen Area Loss Immediately After DCB Implantation by IVUS-OCT Intravascular Imaging.(index PCI)
- Incidence of intolerable adverse events during the duration of coronary artery drug-coated balloon dilation.(index PCI)
- Incidence of patient-oriented composite endpoint (PoCE)(3±1 Months, 6±1 Months, 9±2 Months, 2 Years, 3 Years, 4 Years, and 5 Years after PCI)
- Incidence of Bleeding Academic Research Consortium bleeding type 3 and 5 bleeding complications(3±1 Months, 6±1 Months, 9±2 Months, 2 Years, 3 Years, 4 Years, and 5 Years after PCI)
- Incidence of coronary dissection, categorized by Types A, B, C, and D-F, immediately following DCB implantation(index PCI)
研究者
BAI MING
MD
LanZhou University
研究点 (1)
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