Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,820
- 试验地点
- 53
- 主要终点
- Number of target Lesion Failure (TLF) at 12 Months
研究概览
简要总结
International, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the efficacy, of Magic Touch Sirolimus Coated Balloon (SCB) compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).
详细描述
The purpose of TRANSFORM II study is to observe and evaluate the efficacy of Magic Touch SCB compared to the gold standard treatment for native vessel disease, namely new-generation everolimus-eluting Drug Eluting Stent (DES). Given the inherent and recognized limitations of stents in native vessels with diameter <3 mm, only patients with coronary vessels up to 3.5 mm of diameter (by visual estimation) will be enrolled in this study.
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
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
- •age >18 years;
- •all patients with a clinical indication to Percutaneous Coronary Intervention (PCI) (stable coronary artery disease or acute coronary syndromes);
- •native coronary artery lesion in a vessel with diameter >2.0 mm and ≦3.5 mm at visual estimation;
- •maximum lesion length: 50 mm.
- •informed consent to participate in the study.
排除标准
- •patients with known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, ticagrelor, sirolimus or contrast media, which cannot be adequately pre-medicated;
- •patients participating in another clinical study;
- •subject is a woman who is pregnant or nursing (pregnancy test, either urine or blood test must be performed within 7 days prior to the index procedure in woman of child-bearing potential, and must not commit to initiating a pregnancy for 12 weeks after implantation, using effective contraception);
- •creatinine clearance <30 ml/min;
- •left ventricular ejection fraction <30%;
- •life expectancy <12 months;
- •ST-elevation myocardial infarction in the previous 48 hours;
- •visible thrombus at lesion site;
- •culprit lesion stenosis >99% and/or Thrombolysis In Myocardial Infarction (TIMI) flow <2;
- •target lesion/vessel with any of the following characteristics:
- •concomitant PCI at the same vessel with any device (vessels are considered: left anterior descending, circumflex or right coronary artery);
- •pre-dilatation of the target lesion not performed or not successful (residual stenosis >30%);
- •severe calcification of the target vessel, at lesion site but also proximally;
- •highly tortuous vessel which could impair device delivery to the lesion site following Investigator's judgement;
- •previous stent implantation at target vessel (left anterior descending artery; circumflex artery; right coronary artery);
- •bifurcation lesion where side branch treatment is anticipated;
- •left main stem stenosis >50%;
- •target lesion is in left main stem
- •Lesion is located within asaphenous vein graft
研究组 & 干预措施
Everolimus Eluting Stent
干预措施: Everolimus Eluting Stent (Device)
Magic Touch Sirolimus Coated Balloon
干预措施: Sirolimus Coated Balloon (Device)
结局指标
主要结局
Number of target Lesion Failure (TLF) at 12 Months
时间窗: 12 Months
Non-inferiority of Magic Touch SCB compared to everolimus-eluting DES (EES) in terms of target lesion failure (TLF), a composite clinical endpoint, at 12 months.
Number of NACEs
时间窗: 12 Months
Verify the superiority of the study device in terms of net adverse clinical events (NACE), a composite endpoint including all-cause death, myocardial infarction (MI), ischemic stroke, and major bleedings following the Bleeding Academic Research Consortium (BARC) types 3 or 5 definition.
次要结局
- Bleeding(6, 12, 24, 36, 48 and 60 months)
- MI(6, 12, 24, 36, 48 and 60 months)
- Cardiac death(6, 12, 24, 36, 48 and 60 months)
- Death of any cause;(6, 12, 24, 36, 48 and 60 months)
- Q-wave MI(6, 12, 24, 36, 48 and 60 months)
- Target Lesion Revascularization (TLR)(6, 12, 24, 36, 48 and 60 months)
- Target Vessel Revascularization (TVR)(6, 12, 24, 36, 48 and 60 months)