NL-OMON44708已完成4 期
BIOTRONIK- *A Prospective, Randomized, Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Stent in the Treatment Of Subjects With up to two de novo Coronary Artery Lesions* - IV - BIOFLOW-IV
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Biotronik
- 入组人数
- 83
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Clinical Inclusion Criteria
- •1. Subject must provide written informed consent
- •2. Subject is * 18 years and * 80 years old
- •3. For subject less than 20 years of age enrolled at a Japanese site, the patient and the patient*s legal representative must provide written informed consent before any study-specific tests or procedures are performed
- •4. Subject, target vessel(s) and lesion(s) are eligible for percutaneous coronary intervention (PCI)
- •5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
- •6. Subject has clinical evidence of ischemic heart disease and/or a positive functional study, stable or unstable angina pectoris or documented silent ischemia, attributable to the target lesions
- •7. Subject is eligible for dual anti-platelet therapy (DAPT) treatment with acetylsalicylic acid (ASA) plus either, Clopidogrel, Prasugrel, Ticlopidine, or Ticagrelor. For subjects enrolled at a Japanese site, DAPT with ASA plus either Clopidogrel or Ticlopidine;Angiographic Inclusion Criteria
- •1. The target reference vessel diameter (RVD) is * 2.50 mm and * 3.75 mm assessed either visually or by online Quantitative Coronary Angiography.
- •2. Target lesion length is * 26 mm (assessed either visual estimate or by online Quantitative Coronary Angiography) and can be covered by one study stent
- •3. Single de novo lesion with * 50% and < 100% stenosis in up to 2 coronary arteries
- •4. Target vessel(s) Thrombolysis in Myocardial Infarction (TIMI) flow * 2
排除标准
- •Clinical Exclusion Criteria;1. Subject has evidence of myocardial infarction within 72 hours prior to the index procedure
- •2. Subject with a *2 fold CK level or in absence of CK *3 fold CKMB level above the upper range limit within 24 hours prior to the procedure
- •3. Documented recent left ventricular ejection fraction (LVEF) * 30%
- •4. Subject is receiving oral or intravenous immunosuppressive therapy (i.e., 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)
- •5. Subject has impaired renal function (i.e., serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
- •6. Target vessel(s) or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure
- •7. The target lesion requires treatment with a device other than the pre-dilatation balloon prior to stent placement (including but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, cutting balloon etc.)
- •8. Planned intervention of non-target vessel(s) within 30 days after the index procedure
- •9. Planned intervention of target vessel(s) after the index procedure
- •10. Subject has a known allergy to contrast medium (that cannot be adequately premedicated), acetylsalicylic acid (ASA), heparin, PLLA, sirolimus, everolimus, cobalt chromium, nickel, or silicon carbide.
- •11. Subject is currently participating in another (medical device or drug) clinical study that has not reached the primary endpoint
- •12. Subject is pregnant and/or breast-feeding female or female who intends to become pregnant during the time of the study
- •13. Subject has serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months
- •14. Planned surgery or dental surgical procedure within 6 months after index procedure
- •15. Three-vessel coronary artery disease at time of procedure
- •16. In the investigators opinion subject will not be able to comply with the follow up requirements;Angiographic Exclusion Criteria;1. Target lesion is located in the left main stem
- •2. Target lesion is located in or supplied by an arterial or venous bypass graft
- •3. Target lesion involves a side branch > 2.0 mm in diameter by visual estimate or by online quantitative coronary angiography
- •4. Ostial target lesion (within 5.0mm of vessel origin)
- •5. Thrombus, or possible thrombus, present in the target vessel
- •6. Heavily calcified lesion
- •7. Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off;Note: Multiple focal stenosis will be considered as a single lesion if they can be completely covered with 1 stent
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