NL-OMON46947招募中不适用
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 - BIOSOLVE-II
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Biotronik
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject is >= 18 years and <= 80 years of age
- •2. Written subject informed consent available prior to PCI
- •3. Subjects with stable or unstable angina pectoris or documented silent ischemia
- •4. Subject eligible for PCI
- •5. Subject acceptable candidate for coronary artery bypass surgery
- •6. Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions.
- •7. Reference vessel diameter between 2.2-3.8 mm by visual estimation, depending on the scaffold size used.
- •8. Target lesion length <= 21 mm by visual estimation, depending on the scaffold size used.
- •9. Target lesion stenosis by visual estimation, assisted by QCA / IVUS: >= 50% - < 100%
- •10. Eligible for Dual Anti Platelet Therapy (DAPT)
排除标准
- •1. Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
- •2. Evidence of myocardial infarction within 72 hours prior to index procedure
- •3. 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
- •4. Unprotected left main coronary artery disease
- •5. Three-vessel coronary artery disease at time of procedure
- •6. Thrombus in target vessel
- •7. Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
- •8. Planned interventional treatment of any non-target vessel within 30 days post-procedure
- •9. Subjects on dialysis
- •10. Planned intervention of the target vessel within 6-month after the index procedure
- •11. Ostial target lesion (within 5.0 mm of vessel origin)
- •12. Target lesion involves a side branch >2.0 mm in diameter
- •13. Documented left ventricular ejection fraction (LVEF) <= 30%
- •14. Heavily calcified lesion
- •15. Target lesion is located in or supplied by an arterial or venous bypass graft
- •16. The target lesion requires treatment with a device other than the pre-dilatation balloon or cutting/scoring balloon prior to scaffold placement (including but not limited to rotational atherectomy, etc.)
- •17.Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the respective crossing profile of DREAMS and angiographic complications (e.g. distal embolization, side branch closure, extensive dissections that can*t be covered by a single scaffold), by visual estimation
- •18. Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
- •19. Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
- •20. 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)
- •21. Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
- •22. Life expectancy less than 1 year
- •23. Planned surgery or dental surgical procedure within 6 months after index procedure
- •24. In the investigators opinion subjects will not be able to comply with the follow-up requirements
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