[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gi-bleed\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gi-bleed":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100573170","onyx-liquid-embolic-ide-clinical-study-100573170",false,"NCT06742801","Onyx™ Liquid Embolic IDE Clinical Study","PELE IDE Clinical Study, Peripheral Onyx™ Liquid Embolic Safety and Effectiveness of The Onyx™ LES for Embolization of Arterial Hemorrhage in the Peripheral Vasculature","Inclusion Criteria:\n\n1. Patient is ≥ 22 years old.\n2. Active arterial bleeding in the peripheral vasculature confirmed by radiologic and\u002For endoscopic imaging and deemed suitable for embolization treatment by the investigator.\n\n   In this study, peripheral vasculature is defined as outside the brain and heart.\n3. Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.\n4. Life expectancy of \\>30 days, in the opinion of the investigator at the time of enrollment.\n5. Target treatment area is free from prior embolization treatment.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding.\n2. Symptoms of active infection.\n3. Patient is known to be participating in the study of an investigational drug, biologic, or device.\n4. Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.\n5. Known allergy to components of Onyx™.\n6. Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment.\n7. More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.","ALL","22 Years",{"count":19,"type":20},119,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.",[26,27,28,29,30],"Peripheral Arterial Hemorrhage","Trauma","GI Bleed","Ulcer","Hemorrhage",[26,32],"Embolization treatment","RECRUITING","2026-06-02",{"date":36,"type":37},"2026-06-03","ACTUAL",{"date":39,"type":37},"2025-05-09",{"date":41,"type":20},"2027-05",{"name":43,"class":44},"Medtronic Endovascular","INDUSTRY",18,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100519102","humanmachine-interface-what-the-heartmate-3--device-tells-us-about-the-future-100519102","NCT06039176","Human\u002FMachine Interface: What the HeartMate 3 ® Device Tells Us About the Future","Inclusion Criteria:\n\n* 18 years of age or older\n* Scheduled Heartmate 3 ® dLVAD implantation\n\nExclusion Criteria:\n\n* \\\u003C18 years of age\n* Scheduled for dLVAD that is NOT a Heartmate 3 (R) device","18 Years","100 Years",{"count":55,"type":20},150,"OBSERVATIONAL","Durable left ventricular assist devices (dLVAD) have been increasingly utilized since the mid to late 1990s, with an uptick of utility starting in 2010 following expanded indications for therapy to not only include a bridge to transplantation strategy, but also for those individuals who suffer from advanced heart failure (HF) and do not qualify for cardiac transplantation. Despite the decreasing size of the newest generation devices leading to a lessened occurrence of adverse events, bleeding and infection still remain a concern for clinicians, as well as a general lack of predictability towards adverse events in individuals with a dLVAD in place. There is a lack of description in the literature currently, regarding the interface between what the pump data provides and what is seen in clinical practice. There also is little known about the effects of what is provided in the pump data, in correlation to quality-of-life following dLVAD implantation.\n\nTherefore, the purpose of this study is to prospectively analyze normal and abnormal pump data through pump operations such as suction events, low flow alarms as well as other adventitious alarms, PI events and power cable disconnects greater than 20 seconds, from the HeartMate 3 ® dLVAD in order to clinically correlate this data to quality of life, frailty and other various medical conditions and adverse events as defined by the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs). This will be achieved through two aims: 1) Evaluate the effectiveness of dLVAD pump operations data on clinical practice application (quality of life, frailty and various medical conditions, and adverse events such as GIB, RHF, infection, hypertension, arrhythmias and stroke); and 2) Evaluate correlations and relationships of longitudinal normal and abnormal dLVAD pump operations data, to demographic and clinical variables. This study is the first study to evaluate HeartMate 3 ® dLVAD pump operations data over time for effectiveness in the clinical practice.",[59,60,28,61,62,63,64,65],"LVAD","Frailty","Right Heart Failure","Infections","Hypertension","Arrhythmias","Stroke","2025-12-08",{"date":68,"type":37},"2025-12-16",{"date":70,"type":37},"2023-10-27",{"date":72,"type":20},"2026-12-30",{"name":74,"class":75},"International Consortium of Circulatory Assist Clinicians","OTHER",7]