NCT01844284已完成不适用
A Clinical Evaluation of AVJ-301 (Absorb™ BVS), the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions in Japanese Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 78
- 主要终点
- Number of Participants With Target Lesion Failure (TLF)
研究概览
简要总结
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by comparing to approved metallic drug eluting stent.
详细描述
Absorb™ BVS is currently in development at Abbott Vascular. Not available for sale in the US or Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 20 years of age.
- •Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
- •Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia) suitable for elective percutaneous coronary intervention (PCI).
- •Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- •Subject must be able to take dual antiplatelet therapy for up to 1 year following the index procedure and anticoagulants prior/during the index procedure. Therefore the subject has no known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine or heparin.
- •Female subject of childbearing potential must not be pregnant* at the index procedure and does not plan pregnancy for up to 1 year following the index procedure.
- •* Except for non-pregnancy is apparent, negative pregnancy result within 7 days prior to the index procedure is required.
- •Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
- •Subject agrees to not participate in any other investigational or invasive clinical study for a period of 13 months following the index procedure
排除标准
- •Elective surgery is planned within 1 year after the procedure that will require general anesthesia or discontinuing either aspirin or Thienopyridine.
- •Subject has known hypersensitivity or contraindication to device material and its degredants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
- •Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
- •Subject had an acute myocardial infarction (AMI) within 72 hours of the index procedure
- •The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes
- •Creatine Kinase (CK) and Creatine Kinase - Muscle and Brain (CK-MB) have not returned to within normal limits at the time of index procedure.
- •Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to arrhythmia.
- •Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and the investigator believes it is necessary).
- •The target vessel was treated by PCI within 12 months.
- •Prior PCI within the non-target vessel is acceptable if performed anytime > 30 days before the index procedure or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
- •Subject requires future staged PCI either in target or non target vessels.
- •Subject has a malignancy that is not in remission.
- •Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.,). Note: corticosteroids are not included as immunosuppressant therapy, diabetes mellitus is not regarded as autoimmune disease.
- •Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
- •Subject has previously received or scheduled to receive radiotherapy to coronary artery (brachytherapy), or chest/mediastinum.
- •Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin or any other agent for any reason).
- •Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm
- •Subject has a documented or suspected cirrhosis of Child-Pugh ≥ Class B.
- •Subject has known renal insufficiency;
- •Dialysis at the time of screening.
- •An estimated Glomerular filtration rate (GFR) < 30 ml/min/1.73m2
- •Subject is high risk of bleeding, or difficult to have appropriate treatment;
- •Has a history of bleeding diathesis or coagulopathy
- •Has had a significant gastro-intestinal or significant urinary bleed within the past six months
- •Has prior intracranial bleed
- •Has prior intracranial bleed (including severe permanent neurologic deficit that seem to be caused by previous intracranial bleeding)
- •Has known intracranial pathology that may cause intracranial bleeding per an investigator assessment (e.g. untreated aneurysm > 5 mm, arteriovenous malformation)
- •Subject will refuse blood transfusions
- •Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months,
- •Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
- •Subject has life expectancy < 3 year.
- •Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
- •Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- •Subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g. subordinate hospital staff or sponsor staff) or subject is unable to read or write.
结局指标
主要结局
Number of Participants With Target Lesion Failure (TLF)
时间窗: 1 year
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
次要结局
- Number of Participants With Any Death/Any MI/Revascularization (DMR)(5 years)
- Number of Participants With Target Vessel Failure (TVF)(5 years)
- Number of Participants With Target Lesion Failure (TLF)(5 years)
- Number of Participants With Cardiac Death/All MI(5 years)
- Number of Participants With All Target Vessel Revascularization (TVR)(5 years)
- Number of Participants With Ischemia-driven TVR (ID-TVR)(5 years)
- Number of Participants With All Target Lesion Revascularization (TLR)(5 years)
- Number of Participants With Ischemia-driven Revascularization (ID-TLR)(5 years)
- Number of Participants With Target Vessel MI (TV-MI)(5 years)
- Number of Participants With Stent/Scaffold Thrombosis(Very Late (1461 - 1825 days))
- In-segment Late Loss (Non-inferiority)(13 months)
- Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Pre-Nitroglycerin (NTG)(2 years)
- Nitrate Vaso-reactivity Analysis/ In-device Mean Lumen Diameter: Absolute Vaso Dilatation(2 years)
- Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Post-Nitroglycerin (NTG)(2 years)
- Number of Participants With Cardiac Death, All MI, ID-TLR (MACE)(5 years)
- Number of Participants With Not Ischemia-driven TLR (NID-TLR)(5 years)
- Number of Participants With Non-Target Vessel MI (NTV-MI)(5 years)
- Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)(5 years)
- Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))(5 years)
研究者
研究点 (78)
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