POST-MARKET EVALUATION OF DESolve® NOVOLIMUS ELUTING BIORESORBABLE CORONARY SCAFFOLD SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 7
- 主要终点
- Major Adverse Cardiac Events (MACE)
研究概览
简要总结
To evaluate the long-term safety and performance of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System
详细描述
DESolve is not currently approved for sale in the United States.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be at least 18 years of age
- •Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DESolve NE BCSS and he/she provides written informed consent, as approved by the appropriate Ethics Committee of the respective clinical site, prior to any clinical study related procedure
- •Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or electrocardiogram (ECG) changes consistent with ischemia)
- •Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
- •Patient must agree to undergo all clinical study required follow-up visits
- •Patient must agree not to participate in any other clinical study for a period of two years following the index procedure
- •Angiographic Inclusion Criteria - Target Lesion/Vessel Target lesion must be located in a native coronary artery with a nominal vessel diameter of between 2.75 and 3.5 mm assessed by visual estimation or QCA
- •Target lesion must measure ≤ 24 mm in length
- •Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 90% with a TIMI flow of ≥ 1
- •Percutaneous intervention of lesions in the target vessel if:
- •Not part of a clinical investigation
- •≥ 6 months prior to the study index procedure
- •≥ 9 months after the study index procedure (planned)
- •Previous intervention was distal to and > 10 mm from the target lesion
排除标准
- •Patient has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure
- •Patient is currently experiencing clinical symptoms consistent with AMI
- •Patient requires the use of any rotablator intervention during the index procedure
- •Patient has current unstable arrhythmias
- •Patient has a known left ventricular ejection fraction (LVEF) < 30%
- •Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
- •Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
- •Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus)
- •Patient is receiving chronic anticoagulation therapy (e.g., heparin, Coumadin) that cannot be stopped and restarted according to local hospital standard procedures
- •Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, Novolimus, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated
- •Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
- •Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease
- •Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
- •Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
- •Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
- •Patient has had a significant GI or urinary bleed within the past six months
- •Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
- •Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
- •Patient is already participating in another clinical study
- •Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal (defined as amenorrheic for at least one year) as well as women who are pregnant or nursing
- •Patient is unable to give their consent, is legally incompetent, or is institutionalized by virtue of an order issued by the courts or other authority
- •Angiographic Exclusion Criteria - Target Lesion/Vessel
- •Target lesion(s) meets any of the following criteria:
- •Aorto-ostial location
- •Left main location
- •Located within 5 mm of the origin of the LAD or LCX
- •Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
- •Lesion involving a side branch >2mm in diameter or bifurcation
- •Previous placement of a scaffold proximal to or within 10 mm of the target lesion
- •Total occlusion (TIMI flow 0), or sub-total occlusion (TIMI flow 1)
- •Excessive tortuosity proximal to or within the lesion
- •Angulation (≥ 45o) proximal to or within the lesion
- •Calcification moderate or heavy
- •Previous intervention restenosis
研究组 & 干预措施
DESyne Novolimus Eluting CSS
approved device continued access
干预措施: coronary intervention (Device)
结局指标
主要结局
Major Adverse Cardiac Events (MACE)
时间窗: 5 years
Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization
Major Adverse Cardiac Events (MACE)
时间窗: 1 month
Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization
Major Adverse Cardiac Events (MACE)
时间窗: 6 months
Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization
Major Adverse Cardiac Events (MACE)
时间窗: 12 months
Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization
Major Adverse Cardiac Events (MACE)
时间窗: 2 years
Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization
Major Adverse Cardiac Events (MACE)
时间窗: 3 years
Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization
Major Adverse Cardiac Events (MACE)
时间窗: 4 years
Major Adverse Cardiac Events (MACE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization
次要结局
未报告次要终点