NCT01960504Unknown不适用
BIOTRONIK - Safety and Clinical PerFormance of the Drug Eluting Absorbable Metal Scaffold (DREAMS 2nd Generation) in the Treatment of Subjects With de NOvo Lesions in NatiVE Coronary Arteries: BIOSOLVE-II
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Biotronik AG
- 入组人数
- 123
- 试验地点
- 25
- 主要终点
- In segment Late Lumen Loss
研究概览
简要总结
BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).
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 2.2-3.8 mm by visual estimation
- •Target lesion length ≤ 21 mm by visual estimation
- •Target lesion stenosis by visual estimation, assisted by QCA / IVUS: > 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
- •Unprotected 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 within 6-month 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, rotational atherectomy, cutting balloon etc.)
- •Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
- •Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
- •Subject is receiving oral or intravenous immuno-suppressive therapy (e.g., 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
- •Planned surgery or dental surgical procedure within 6 months after index procedure
- •In the investigators opinion subjects will not be able to comply with the follow-up requirements
结局指标
主要结局
In segment Late Lumen Loss
时间窗: 6 months post index procedure
次要结局
- Target Lesion Failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularisation (TLR)(1, 6, 12, 24 and 36 months)
- Scaffold thrombosis rate(1, 6, 12, 24 and 36 months)
- Late Lumen Loss in scaffold(6 and 12 months)
- Procedure success(During the hospital stay to a maximum of the first seven days post index procedure)
- Device success(Day 0)
- In-scaffold and in-segment Binary Restenosis Rate(6 and 12 months)
- In-scaffold and in-segment Percent Diameter Stenosis(6 and 12 months)
- Late Lumen Loss in segment(12 months)
研究者
研究点 (25)
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