EUCTR2020-005933-34-AT进行中（未招募）1 期
Evaluation of a modified Anti-Platelet Therapy associated with low-dose rapamycin DES Firehawk in Acute Myocardial Infarction Patients treated with complete revascularization strategy - TARGET FIRST
Sorin CRM SAS (Microport CRM)0 个研究点目标入组 2,246 人开始时间: 2021年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,246
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all of the following criteria to be eligible for enrolment:
- •Subject is = 18 years old
- •Subject has been hospitalised for troponin-positive Non-ST-Elevation MI, requiring early invasive treatment (PCI), or ST-Elevation MI requiring primary PCI, and this PCI occurred within the last 7 days
- •Subject is eligible for per-protocol antiplatelet treatments
- •Subject understands and agrees with the trial requirements and procedures, and provides written informed consent before any trial-specific tests or procedures are performed
- •Subject is willing to comply with all protocol requirements including antiplatelet treatment strategies and follow-up visits
- •Procedural/angiographic (related to the treatment of the (N)STEMI
- •Successful revascularization:
- •-Successful delivery and deployment of the Firehawk stent(s), with final residual stenosis of <30% (visually) for all target lesions
- •-No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication/bleeding).
- •All the treated lesions:
- •-In native coronary arteries only,
- •-In vessels with visual reference diameter =2.25 mm and = 4.00 mm
- •-Implanted with the study device
- •-Maximum 3 lesions treated (*)
- •-Maximum total stent length = 80 mm.
- •Complete revascularization (**) performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 7 days from the index procedure. Physiologic assessment highly recommended for lesions with stenosis between 50% and 69%.
- •(*) in 1 to 3 vessels.
- •(**) Complete revascularization performed according to site routine practice and according to the European Society of Cardiology (ESC) guidelines.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 800
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1446
排除标准
- •Patients fulfilling any of the following criteria are not eligible:
- •Subjects with prior STEMI or prior PCI within 12 months before index admission
- •Prior Coronary Artery Bypass Graft (CABG) Surgery
- •Cardiogenic shock
- •Secondary PCI
- •Fibrinolysis
- •Prior stent thrombosis
- •Planned PCI, CABG, or surgery within 12 months after the enrolment
- •Need for Oral Anti-Coagulation medications (or NOAC)
- •Ischemic stroke or intracerebral hemorrhage (spontaneous or traumatic) within 12 months prior to index procedure
- •eGFR <30 mL/min/1.73 m2 or dialysis
- •Active bleeding at time of inclusion or high risk for major bleeding
- •History of bleeding diathesis or coagulopathy or subject refuse blood transfusions
- •Stage B or C liver cirrhosis or active cancer within 12 months prior to index procedure (or currently receiving chemotherapy or planned to receive chemotherapy)
- •Baseline haemoglobin <13 g/dL (12g/dL for women) or anaemia requiring transfusion in the 4 weeks prior to index procedure
- •Moderate or severe thrombocytopenia (<100,000/µL)
- •Expected non-adherence to study protocol (such as current problems with substance abuse, severe impairment of cognitive skills, …)
- •Estimated life expectancy =12 months
- •Known hypersensitivity or contraindication to any medication used in the study or any of the study stent’s components/compounds (e.g., cobalt chromium alloy, rapamycin, or structurally related compounds, polymer or individual components, P2Y12 inhibitors, or aspirin).
- •Subject participates in another interventional (device or drug) clinical trial within 12 months after the index procedure
- •Subject is a woman who is pregnant, nursing or with known intention to procreate within 12 months after the index procedure (woman of child-bearing potential who is sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)). Investigator may require a pregnancy test to be performed within 7 days prior to the enrolment in women of child-bearing potential)
- •Angiographic:
- •-In-stent restenosis or thrombosis
- •-Chronic total occlusion
- •-Severe calcification
- •-True bifurcation disease (Medina class x,x,1) and side branch diameter = 2mm (visual reference visual diameter) or bifurcation treated with 2 stents
- •-Left main coronary artery lesion
- •-Residual untreated dissection = C
- •-Implantation of a non-study stent
- •Extent and severity of disease is such that patient is deemed to receive preferentially CABG within 1 year (based on current ESC guidelines)
研究者
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