NCT01008085已完成3 期
Randomized Comparison Between the STENTYS Self-expanding Coronary Stent and a Balloon-expandable Stent in Acute Myocardial Infarction - APPOSITION II
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Stentys
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Stent strut apposition measured by optical coherence tomography (OCT)
研究概览
简要总结
Study hypothesis: the Stentys self-expandable Stent results into a better alignment of the struts to the vessel wall than a balloon-expandable stent within a few days after the procedure in acute myocardial infarction patients.
详细描述
Stent strut malapposition and stent underexpansion are a common phenomenon in AMI as a result of the changing anatomy after an AMI has occurred (thrombus dissolution, resolution of spasm) with the traditional balloon-expandable stent treatment. A self-expanding stent might lead to better stent strut apposition as it follows the contours of the vessel wall due to its self-expanding properties. This might result into better long term clinical outcomes like lower thrombosis rates.
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
- 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
- •Subject 18 years old.
- •Acute Myocardial Infarction defined as presence of at least two of the three items below:
- •Detection of rise of cardiac biomarkers with a least one value above the 99th percentile of the upper reference limit (URL)
- •Symptoms of ischaemia (chest pain) >20 minutes
- •ECG changes indicative of new ischaemia: new ST-T changes (ST deviation ≥0.2mV precordial leads and/or ≥0.1mV limb leads) or new LBBB)
- •Reperfusion expected to be achieved within 12 hours from the onset of symptoms
- •Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
- •Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone.
- •Acceptable candidate for coronary artery bypass graft (CABG) surgery.
- •Male or non-pregnant female subject.
- •Angiographic Inclusion Criteria:
- •Reference vessel diameter >2.5mm and <4.0mm by visual estimate.
- •Target lesion <30mm in length by visual estimate
排除标准
- •Currently enrolled in another investigational device or drug study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- •Coronary or cardiac intervention or major surgery of any kind within 30 days prior to the procedure.
- •Target vessel supplied by by-pass vessel
- •Patients on anticoagulation therapy (Coumadin)
- •Patient received thrombolytic therapy.
- •Myocardial infarction due to stent thrombosis, or infarct lesion at the side of a previously implanted stent
- •Cardiogenic shock
- •Any previous stent placement within 10mm (proximal or distal) of the target lesion.
- •Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study.
- •Concurrent medical condition with a life expectancy of less than 6 months.
- •Left ventricular ejection fraction (LVEF) <30% at the most recent evaluation.
- •Cerebrovascular accident or transient ischemic attack in the last 6 months.
- •Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, or sensitivity to contrast media, which cannot be adequately pre-medicated.
- •Known serum creatinine level >2.5mg/dl or presence or history of renal failure
- •Angiographic Exclusion Criteria:
- •Unprotected left main coronary artery disease (obstruction greater than 50% in the left main coronary artery that is not protected by at least one non-obstructed bypass graft to the left anterior descending (LAD) or left circumflex (LCX) artery or a branch thereof).
- •Target vessel is excessively tortuous (two bends >90˚ to reach the target lesion).
- •Lesion location that is aorto-ostial or within 5mm of the origin of the LAD or LCX.
- •Target lesion is severely calcified.
结局指标
主要结局
Stent strut apposition measured by optical coherence tomography (OCT)
时间窗: 3 days after procedure
次要结局
- Stent thrombosis(30 days and 6 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis StudyBiliary StrictureNCT01543256Boston Scientific Corporation172
已完成
不适用
EUS-guided Transmural Drainage of Walled-off Pancreatic Necrosis: Plastic vs Metallic Protesis.Pancreas NecrosisPancreatic CollectionNCT03100578Hospital Universitari de Bellvitge99
Unknown
不适用
The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed StentsMalignant Gastric Outlet ObstructionNCT02440724Asan Medical Center33
已完成
不适用
The influence of Stentys self-apposing stent on the lipid-core burden index assessed with near-infrared spectroscopy: could Stentys potentially prevent periprocedural MIs?NL-OMON39928Academisch Medisch Centrum30
终止
4 期
Iliac, Common and External (ICE) Artery Stent TrialVascular LesionsNCT01305174Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.660