NL-OMON38520已完成不适用
STENTYS Coronary Stent System Clinical Trial in Patients with Acute Myocardial Infarction - APPOSITION V
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- STENTYS
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject * 18 years old.
- •2. Subject experiencing clinical symptoms consistent with AMI of >30 min. in duration.
- •3. ST elevation *1 mm in *2 contiguous leads or new left bundle branch block, or true posterior MI with ST depression of *1 mm in *2 contiguous anterior leads.
- •4. Symptom duration is <12 hours prior to signing informed consent.
- •5. Subject should be in catheterization laboratory and procedure started within 2 hours of consent.
- •6. Patient provides written informed consent.
- •7. Patient agrees to all required follow-up procedures and visits.;Angiography:
- •1. Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated use of stenting.
- •2. The vessel diameter is either known or expected to be 2.5-4.0 mm, without excessive tortuosity or diffuse distal disease.
- •3. Lesion length *12mm and * 23mm
排除标准
- •1. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- •2. A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
- •3. Female patients of childbearing potential known to be pregnant.
- •4. Patients undergoing cardiopulmonary resuscitation.
- •5. Cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or emergency IABP for hypotension).
- •6. The subject requires multi-vessel PCI at time of index procedure or any staged procedure of the target vessel within 9 months or any non-target vessel within 30 days post-procedure.
- •7. The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.). Thrombus aspiration may be used per operator discretion.
- •8. Attempted thrombolysis.
- •9. Co-morbid condition(s) that could limit the subject*s ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
- •10. Concurrent medical condition with a life expectancy of less than 12 months.
- •11. Known left ventricular ejection fraction (LVEF) < 25% at the most recent evaluation (prior to the index hospitalization).
- •12. History of cerebrovascular accident or transient ischemic attack in the last 6 months.
- •13. Active peptic ulcer or active gastrointestinal (GI) bleeding.
- •14. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
- •15. 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.
- •16. Known serum creatinine level > 2.5 mg/dl, eGFR <30, or hemodialysis dependent. ;Angiography:
- •1. Unprotected left main coronary artery disease (obstruction greater than 60% 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).
- •2. Multi-vessel intervention required during the index procedure.
研究者
相似试验
已完成
不适用
*MGuard* Prime Stent System Clinical Trial in Patients with Acute ST Elevation Myocardial Infarction*.acute ST elevation myocardial infarction (STEMI)10028593NL-OMON38630InspireMD, Inc.110
已完成
不适用
Qvanteq Bioactive Coronary Stent System First in Man (FIM) Clinical Investigatiomyocardial ischemia and coronary atherosclerosis10011082NL-OMON40746QVANTEQ14
已完成
2 期
Axetis Inert Coronary Stent System First in Man (FIM) Clinical InvestigatioCoronary artery diseasecoronary artery stenosis10011082NL-OMON40619Axetis AG35
已完成
不适用
Svelte SOAW Coronary Stent Clinical Observational Studyanginacoronary artery disease10011082NL-OMON33323Svelte Medical Systems, Inc20
已完成
不适用
Vascular Implant Safety and Efficacy StudyCoronary Artery DiseaseNCT03263858Biotronik CRC Inc.66