NCT02716220已完成不适用
BIOTRONIKS - Acute Performance Of a Drug Eluting Absorbable Metal Scaffold (DREAMS 2G) in Patients With de Novo Lesions in NatiVE Coronary Arteries: BIOSOLVE-III
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biotronik AG
- 入组人数
- 61
- 试验地点
- 16
- 主要终点
- Acute performance of the DREAMS 2G
研究概览
简要总结
BIOSOLVE-III Study is a pre-market, prospective, multi-center trial to assess the acute clinical performance of the DREAMS 2G Drug-Eluting Coronary Scaffold in de novo coronary artery lesions.
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
- •Subjects with stable or unstable angina pectoris or documented silent ischemia
- •Subject eligible for PCI
- •Subject acceptable candidate for coronary artery bypass surgery
- •Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions.
- •Reference vessel diameter between 2.7-3.8 mm by visual estimation, depending on the scaffold size used.
- •Target lesion length by visual estimation, assisted by QCA: < 21 mm, depending on the scaffold size used.
- •Target lesion stenosis by visual estimation, assisted by QCA > 50% - < 100%
- •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
- •Evidence of myocardial infarction within 72 hours prior to index procedure
- •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 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
- •Subjects on dialysis
- •Planned intervention of the target vessel after the 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%
- •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 scaffold 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 DREAMS 2G 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 221mmol/l) determined within 72 hours prior to intervention
- •Subject is receiving oral or intravenous immuno-suppressive 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 1 year, or other co-morbidities (e.g. Sepsis, Apoplexy or TIA within 6 months prior to the study procedure) (Co-morbidities definitions will be left to the discretion of the Study Investigators)
- •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
Acute performance of the DREAMS 2G
时间窗: During the hospital stay to a maximum of 7 days post study Procedure
Acute performance of the DREAMS 2G assessed by procedure success. Procedure success is defined as: Procedure Success is defined as achievement of a final diameter stenosis of \<30% by QCA (using any percutaneous method) without the occurrence of death, Q-wave or non-Q-wave MI, or repeat revascularization of the target lesion during the hospital stay
次要结局
- Scaffold thrombosis rate(1, 6 12, 24 and 36 months post procedure)
- Target Lesion Failure (TLF)(1, 6 12, 24 and 36 months post procedure)
- Binary in-scaffold and in-segment restenosis rate(12-months)
- In-segment late lumen loss(12-months)
- In-scaffold late lumen loss(12-months)
- % in-scaffold and in-segment diameter stenosis(12-months)
研究者
研究点 (16)
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