Optical Coherence tOmography Based Edge and In-stent Vascular Response After a Novel bioDegradable Polymer sIrolimus-eLuting Stent in patIents With Non-ST Elevation acuTe Coronary sYndrome (NSTE ACS)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 主要终点
- Proportion of uncovered and/or malapposed bioDegradable polymer sIrolimus-eLuting stent at 12 month after the implant, as measured by OCT
研究概览
简要总结
This study evaluates the completeness of strut coverage and vessel wall response, at different time points (3-6-12 Months), following CordimaxTM stent implantation in patients with non-ST elevation acute coronary syndrome
详细描述
Major concerns were addressed to the delayed healing process of drug-eluting stents . To date no studies have detailed the in-vivo completeness of CordimaxTM stent coverage at different time points. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (neointima disomogeneity, acquired late incomplete strut apposition) at different time points following CordimaxTM stent implantation, in patients with non-ST elevation acute coronary syndrome . Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at different time points (3-6-12 Months)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 and ≤ 75 years
- •Non-ST-segment elevation MI
- •Patient willing to comply with specified follow-up
- •5.Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent 6.Single or two de novo or non-stented restenotic lesion in a native coronary artery
- •Target lesion to be covered by a single stent of max 30 mm . Reference vessel diameter ≥2.25 to ≤ 4.0 mm by visual estimate
- •The vessel diameter should be measured after pre-dilation procedure and after intra-coronary nitroglycerin if spasm is suspected
- •Target lesion ≥70% stenosed by visual estimate
排除标准
- •Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test
- •Impaired renal function or on dialysis
- •Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC<3,000 cells/mm3
- •Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
- •Patient requires low molecular weight heparin (LMWH) treatment postprocedure or has received a dose of LMWH ≤8 hours prior to index procedure
- •Patient has received any organ transplant or is on a waiting list for any organ transplant;
- •Patient has other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (<1 year)
- •Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy, sirolimus and/or contrast sensitivity that cannot be adequately pre-medicated
- •Patient has previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies
- •Patient presents with cardiogenic shock
- •Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion;
- •Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study
- •Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up
- •Calcified target lesion(s) which cannot be successfully predilated
- •Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
结局指标
主要结局
Proportion of uncovered and/or malapposed bioDegradable polymer sIrolimus-eLuting stent at 12 month after the implant, as measured by OCT
时间窗: 12 month
次要结局
未报告次要终点