NCT04157153进行中（未招募）不适用
BIOTRONIK - Safety and Clinical Performance of the - Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Biotronik AG
- 入组人数
- 116
- 试验地点
- 14
- 主要终点
- In scaffold late lumen loss
研究概览
简要总结
A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.
详细描述
Clinical follow-up visits will take place at 1, 6, and 12 months and annually thereafter until 60 months post procedure.
All subjects will undergo an angiographic follow-up at 6- and 12-month follow up.
IVUS, (including IVUS-VH documentation) and OCT will be performed for all subjects at 6-month and 12-month follow-up (if the safety of the subject allows it and as per the investigator's decision).
Vasomotion will be assessed angiographically with Acetylcholine followed by Nitroglycerine at 12 months follow up in a subgroup of subjects, upon the investigators discretion and if subject consents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject is > 18 years and < 80 years of age
- •Written subject informed consent available prior to PCI
- •Subject eligible for PCI
- •Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions and can be covered with 1 device each
- •Reference vessel diameter between 2.5-4.2 mm by visual estimation, depending on the scaffold size used
- •Target lesion length ≤ 28 mm by visual estimation, depending on the scaffold size used
- •Target lesion stenosis by visual estimation > 50% - < 100% and TIMI flow ≥1 (assisted by e.g. QCA / IVUS /FFR).
- •Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients without angiographic evidence of thrombus at target lesion
- •Eligible for Dual Anti Platelet Therapy (DAPT)
排除标准
- •Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
- •Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure.
- •Left main coronary artery disease
- •Three-vessels with coronary artery disease requiring treatment at time of procedure
- •Planned interventional treatment of any non-target vessel within 12-month post-procedure
- •Subjects on dialysis
- •Planned intervention of the target vessel post index procedure
- •Ostial target lesion (within 5.0 mm of vessel origin)
- •Target lesion involves a side branch >2.0 mm in diameter
- •Documented left ventricular ejection fraction (LVEF) ≤ 30% within the last 6 months
- •Heavily calcified lesion
- •Target lesion is located in or supplied by an arterial or venous bypass graft
- •Target lesion requiring treatment with a device other than the non-compliant pre-dilatation balloon or scoring balloon prior to scaffold placement (including but not limited to rotational atherectomy, etc.)
- •Unsuccessful pre-dilatation, defined as a residual stenosis rate more than 20%, estimated by any method and/or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections)
- •Known allergies to: Acetylsalicylic Acid (ASA), P2Y12 inhibitors, Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
- •Subject is receiving an oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has a known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus) diabetes mellitus is not excluded)
- •A stenosis located proximal or distal to the target lesion that might require future revascularization or an impede run off detected during diagnostic angiography
- •Life expectancy less than 1 year
- •Planned surgery or dental surgical procedure within 6 months after index procedure unless DAPT will be maintained
- •In the investigators opinion, subject will not be able to comply with the follow-up requirements
- •Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
结局指标
主要结局
In scaffold late lumen loss
时间窗: At 6 months after index procedure
Independent Core Lab Assessment
次要结局
未报告次要终点
研究者
研究点 (14)
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