A NON-RANDOMIZED, CONSECUTIVE ENROLLMENT EVALUATION OF THE DESolveTM MYOLIMUS ELUTING BIORESORBABLE CORONARY STENT 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
- 16
- 试验地点
- 6
- 主要终点
- Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
研究概览
简要总结
This prospective, consecutive enrolment, single-arm study will enroll up to 15 patients with single de novo, Type A lesions < 10 mm in length and located in a native coronary artery with a reference vessel diameter of 2.75 mm - 3.0 mm as measured by both offline QCA and IVUS. All patients will receive a 3.0 x 14mm DESolve Stent loaded with approximately 40 mcg of Myolimus.
- Angiographic and intravascular ultrasound (IVUS) will be completed for all patients at baseline and at 6 months.
- Optical Coherence Tomography (OCT) will will be completed for all patients at baseline and at 6 months.
- Multi-slice computed tomography (MSCT) will be conducted on all patients enrolled at 12 and 24 months.
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 Myolimus Eluting BCSS and he/she or his/her legally authorized representative 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 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, angiograms, IVUS, OCT and MSCT
- •Patient must agree not to participate in any other clinical study for a period of two years following the index procedure
排除标准
- •Patients 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
- •The patient is currently experiencing clinical symptoms consistent with AMI
- •Patient has current unstable arrhythmias Patient has undergone previous percutaneous interventions for lesions in either a non-target vessel or target vessel Patient has undergone previous percutaneous interventions for lesions in either a non-target vessel or target vessel
- •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 etc.)
- •Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
- •Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, Myolimus, 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 7 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 is not post-menopausal (defined as amenorrheic for at least one year)
结局指标
主要结局
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
时间窗: 5 years
Clinically-Indicated Target Vessel Revascularization (CI-TVR)
时间窗: 5 years
Clinically-Indicated Target Lesion Failure (CI-TLF)
时间窗: 5 years
Stent thrombosis
时间窗: 5 years
Acute success - Procedure success
时间窗: 7 days
Acute Success is classified according to the following definitions: Procedure success - Attainment of final result, \< 50% residual stenosis of the target site, using the DESolve Myolimus Eluting BCSS device without the occurrence of in-hospital any Major Adverse Cardiac Endpoints.
Acute success - Device success
时间窗: 7 days
Acute Success is classified according to the following definitions: Device success - Attainment of final result, \< 50% residual stenosis of the target site, using the study stent without the need for other non-study stents.
Clinically-Indicated Target Vessel Failure (CI-TVF)
时间窗: 5 years
次要结局
未报告次要终点