NCT02916485暂停不适用
BIOTRONIK - Safety and Clinical Performance Of the Magmaris Drug Eluting Absorbable Metal Scaffold in a Cohort of Patients in India With de Novo Lesions in NatiVE Coronary Arteries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Biotronik AG
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Target lesion failure
研究概览
简要总结
Assessment of the clinical performance and the safety of the Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold in a cohort of patients in India with de novo coronary artery lesions.
详细描述
This is a prospective, multi-centre, single-arm, open label trial to assess the safety and clinical performance of Magmaris Drug Eluting Absorbable Metal Scaffold.
A total of up to 110 patients with de novo lesions in native coronary arteries will be enrolled at up to 8 investigational sites in India.
In-hospital clinical follow-up visits will take place at 1 and 6 months post procedure.
The primary endpoint is target lesion failure (a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction, coronary artery bypass grafting, clinically driven target lesion revascularization) at 1 month post procedure.
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 percutaneous coronary intervention (PCI). Remark: Vulnerable subjects may not be enrolled in this trial
- •Subject with stable or unstable angina pectoris or documented silent ischemia
- •Subject eligible for PCI
- •Subject acceptable candidate for coronary artery bypass surgery
- •Subject with a maximum of two single de novo lesions in two different major epicardial vessels
- •Reference vessel diameter between 2.7-3.7 mm by visual estimation, depending on the scaffold size used
- •Target lesion length ≤ 21 mm by visual estimation, depending on the scaffold size used
- •Target lesion stenosis by visual estimation ≥ 50% - < 100% and TIMI flow ≥1
- •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. Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment
- •Subjects with a ≥2 fold CK level or in absence of CK a ≥3 fold CKMB level above the upper range limit within 24 hours prior to the index procedure
- •Left main coronary artery disease
- •Three-vessel coronary artery disease at time of procedure
- •Thrombus in target vessel
- •Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
- •Planned interventional treatment of any non-target vessel within 30 days post-procedure
- •Subject is on dialysis
- •Planned intervention of the target vessel after the index procedure
- •Ostial target lesion (within 3.0 mm of vessel origin)
- •Target lesion involves a side branch >2.0 mm in diameter
- •Documented left ventricular ejection fraction (LVEF) ≤ 30%
- •Heavily calcified lesion
- •Target lesion is located in or supplied by an arterial or venous bypass graft
- •The target lesion requires treatment with a device other than the pre-dilatation balloon prior to the Magmaris study device placement (including but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
- •Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the respective crossing profile of the Magmaris study device and angiographic complications (e.g. distal embolization, side branch closure, extensive dissections that can't be covered by a single scaffold), by visual estimation
- •Known allergies to: Acetylsalicylic Acid (ASA), Heparin, contrast medium, Sirolimus, Everolimus or similar drugs (i.e., ABT 578, Biolimus, Tacrolimus), PLLA, Silicon Carbide, Magnesium, Yttrium, Neodymium, Zirconium, Gadolinium, Dysprosium, Tantalum
- •Impaired renal function (serum creatinine > 2.5 mg/dl or 221 µmol/l) determined within 72 hours prior to index procedure
- •Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are not excluded) or has known life limiting immunosuppressive or autoimmune disease (e.g.,human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
- •Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
- •Life expectancy less than 6 months
- •Planned surgery or dental surgical procedure within 6 months after index procedure
- •Subject with tortuous vessel that may impair scaffold placement in the region of obstruction or proximal to the lesion
- •In the investigators opinion subjects will not be able to comply with the follow-up requirements.
结局指标
主要结局
Target lesion failure
时间窗: 1 month post-procedure
TLF is a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), coronary artery bypass graft (CABG), clinically driven target lesion revascularization (TLR)
次要结局
- Myocardial infarction(1 and 6 months post-procedure)
- Scaffold thrombosis(1 and 6 months post-procedure)
- Incidence of procedure success(3 days (plus or minus 2 days))
- Incidence of device success(Participants will be followed for the duration of index procedure, an expected average of 1 hour.)
- Target lesion failure (TLF)(6 months post-procedure)
- Clinically driven target lesion revascularization(1 and 6 months post-procedure)
- Cardiac death(1 and 6 months post-procedure)
- Target vessel failure (TVF)(1 and 6 months post-procedure)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery LesionsAtherosclerosis, CoronaryIschemic Heart DiseaseAcute Coronary SyndromeCoronary Artery DiseaseMyocardial IschemiaAngina PectorisNCT02389946Biotronik, Inc.1,334
已完成
2 期
A Study of the SMART Stent in the Treatment SFA Disease.Peripheral Artery DiseaseNCT00232869Cordis Corporation93
进行中（未招募）
不适用
The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary ArteriesCoronary Artery StenosisCoronary DiseaseCoronary StenosisCoronary Artery DiseaseNCT04192747Elixir Medical Corporation445
进行中（未招募）
不适用
BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IVCoronary Artery DiseaseNCT02817802Biotronik AG2,066
已完成
不适用
A Safety and Efficacy of Supralimus™ Core™ Sirolimus Eluting Stent at MAX DDHV InstituteCoronary Artery DiseaseNCT00811616Sahajanand Medical Technologies Limited105