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
干预措施
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
研究组 & 干预措施
Treatment
Experimental
All subjects will be implanted with the Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold System (DREAMS 3G) and followed up until 60 months.
干预措施: Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold (Device)
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)
Loading locations...
相似试验
已完成
不适用
BIOTRONIK Orsiro Pre-Marketing RegistrationCoronary Artery DiseaseNCT02870985Biotronik (Beijing) Medical Device Ltd.440
已完成
不适用
BRight DCB First-in-Human StudyPeripheral Artery DiseaseNCT04525794Biotronik CRC Inc.48
已完成
不适用
BIOLUX P-II First-in-Man Study to Compare the Passeo-18 Lux DRB Against POBA in Infrapopliteal ArteriesPeripheral Artery DiseaseArteriosclerosisVascular DiseaseAtherosclerosisNCT01867736Biotronik AG72
Unknown
不适用
First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)Coronary Artery StenosisCoronary Artery DiseaseNCT01960504Biotronik AG123
已完成
1 期
Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung CancerNon-small Cell Lung Cancer (NSCLC)Lung MetastasisNCT02916745Concordia Laboratories Inc.5