NL-OMON38630已完成不适用
*MGuard* Prime Stent System Clinical Trial in Patients with Acute ST Elevation Myocardial Infarction*. - Master II study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
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
- •General Inclusion Criteria
- •1. Subject is * 18 years of age.
- •2. Subject is experiencing clinical symptoms consistent with acute myocardial infarction (AMI) of >30 minutes and *12 hours in duration.
- •3. ST elevation *2 mm per lead in *2 contiguous leads is present in one ECG prior to consent.
- •4. Subject agrees to all required follow-up procedures and visits.
- •5. Subject provides written, informed consent.;Angiographic Inclusion Criteria
- •1. The target lesion is a de novo lesion in a native coronary artery.
- •2. Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated use of stenting.
- •3. The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0 mm by visual assessment, assessed either at baseline (if direct stenting is planned), or after pre-dilatation or thrombus aspiration (if direct stenting is not planned).
- •4. The entire lesion length requiring treatment is *24 mm (able to be covered by a single study stent), assessed either at baseline (if direct stenting is planned), or after pre-dilatation or thrombus aspiration (if direct stenting is not planned)
- •5. TIMI flow of 2/3 is present prior to randomization (in case of baseline TIMI flow 0/1, blood flow must be restored).
排除标准
- •General Exclusion Criteria
- •1. Left bundle branch block (LBBB), paced rhythm, or other ECG abnormality interfering with assessment of ST-segment.
- •2. 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.
- •3. A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
- •4. Female patients of childbearing potential.
- •5. Subject undergoing cardiopulmonary resuscitation (patients in whom cardiopulmonary resuscitation was successfully performed and in whom normal mental status was achieved, may be enrolled).
- •6. Cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or intra-aortic balloon bump (IABP) or other hemodynamic support device for hypotension).
- •7. The subject requires a staged procedure of the target vessel (including branches) within 12 months or of any non-target vessel within 7 days post-procedure.
- •8. The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to excimer laser, rotational atherectomy, etc.). Manual thrombus aspiration may be used per operator discretion, but rheolytic thrombectomy is only permitted for procedural complications after randomization.
- •9. Prior administration of thrombolytic therapy for the current admission
- •10. 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.
- •11. Concurrent medical condition with a life expectancy of less than 12 months.
- •12. History of cerebrovascular accident or transient ischemic attack within the last 6 months, or any permanent neurologic deficit
- •13. Prior intracranial bleed at any time, or known intracranial pathology (e.g. tumor, arteriovenous malformation, or aneurysm).
- •14. Active or recent site of major bleeding within 6 months.
- •15. History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
- •16. Known hypersensitivity or contraindication to either i) aspirin, or heparin and bivalirudin; or ii) clopidogrel , ticlopidine, prasugrel and ticagrelor; or iii) cobalt or nickel; or iv) contrast media, which cannot be adequately pre-medicated (prior anaphylaxis, however, is an absolute contraindication to enrollment).
- •17. Known serum creatinine level >2.5 mg/dl, hemoglobin <10 g/dL or platelet count <150,000 for the present admission or within 7 days prior to index procedure, if available. NOTE: Baseline labs do not have to be available to consent patient. If laboratory results become available only after randomization, and do not meet inclusion and exclusion criteria, the patient will not be de-registered from the study.
- •18. Surgery planned or any other reason necessitating discontinuation of dual anti-platelet therapy (aspirin and an ADP antagonist) within 12 months
- •19. Aortic dissection or mechanical complication of STEMI (papillary muscle rupture, ventricular septal defect or free wall rupture with or without pseudoaneurysm) identified by echocardiography or other means;Angiographic Exclusion Criteria
- •1. Unprotected left main stenosis *50%.
- •2. Multi-vessel intervention required during the index procedure.
- •3. Excessive tortuosity, calcification or diffuse distal disease is present either proximal to, at or dista
研究者
相似试验
终止
不适用
MGuard™ Prime Stent System Clinical Trial in Patients With Acute ST Elevation Myocardial InfarctionST Elevation Myocardial InfarctionNCT01869738InspireMD310
已完成
不适用
STENTYS Coronary Stent System Clinical Trial in Patients with Acute Myocardial InfarctioHeart-attack10011082Myocardial InfarctionNL-OMON38520STENTYS120
已完成
不适用
Qvanteq Bioactive Coronary Stent System First in Man (FIM) Clinical Investigatiomyocardial ischemia and coronary atherosclerosis10011082NL-OMON40746QVANTEQ14
招募中
2 期
Primary percutaneous placement of metal stents for palliative biliary drainage in patients with a primary malignant perihilar stricturebile duct cancerMalignant biliary hilar stricture10004606NL-OMON56129Erasmus MC, Universitair Medisch Centrum Rotterdam112
招募中
不适用
Primary percutaneous placement of metal stents for palliative biliary drainage in patients with a primary malignant perihilar stricturePerihilar cholangiocarcinoma (pCCA), galbladder carcinoma (GBC), intrahepatic cholangiocarcinoma (iCCA)NL-OMON22038Erasmus MC37