[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Supira Medical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100615756","pivotal-study-of-the-supira-system-in-patients-undergoing-high-risk-percutaneous-coronary-intervention-hrpci-100615756",false,"NCT07296744","Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)","Pivotal Randomized Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)","SUPPORT II","Inclusion Criteria:\n\n* Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary, as determined by the institutional Heart Team\n* Informed consent granted by the subject or legally authorized representative\n\nExclusion Criteria:\n\n* Cardiogenic shock or acutely decompensated pre-existing chronic heart failure\n* Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit\n* Left ventricular thrombus\n* Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device or the comparator device\n* Ongoing renal replacement therapy with dialysis\n* Presence of decompensated liver disease; severe liver dysfunction\n* Infection of the proposed procedural access site or active infection\n* Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or known hypersensitivity to heparin, aspirin, adenosine diphosphate (ADP) receptor inhibitors, or nitinol\n* Any condition, coagulopathy, planned procedure or contraindication that requires discontinuation of antiplatelet and\u002For anticoagulant therapy within 90 days of the index procedure\n* Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure\n* Currently participating in active follow-up phase of another clinical study of an investigational drug or device or planning to enroll in such a study within 90 days of the HRPCI procedure\n* Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and\u002For to comply with study procedures\n* Considered to be part of a vulnerable population per the investigator's assessment","ALL","18 Years","90 Years",{"count":21,"type":22},358,"ESTIMATED","INTERVENTIONAL",[25],"NA","The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device).",[28,29,30,31],"Coronary Artery Disease","High Risk Percutaneous Coronary Intervention","Interventional Cardiology","Mechanical Circulatory Support",[33,34,31,35],"Percutaneous ventricular assist device","Supira System","US Pivotal","RECRUITING","2026-06-10",{"date":39,"type":40},"2026-06-11","ACTUAL",{"date":42,"type":40},"2026-05-11",{"date":44,"type":22},"2027-11",{"name":46,"class":47},"Supira Medical","INDUSTRY",14,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100624298","feasibility-study-of-the-supira-system-in-patients-undergoing-hrpci-with-support-beyond-the-pci-procedure-100624298","NCT07407816","Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure","Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) Who May Benefit From Mechanical Circulatory Support Beyond the PCI Procedure","Inclusion Criteria:\n\n* Subject has pre-existing heart failure, with NYHA Class II, III or IV prior to the index admission and documented LVEF ≤ 45%\n* Subject is presenting with one of the following criteria: unprotected left main coronary artery (ULMCA) disease, last patent vessel, or 3-vessel disease\n* Subject may benefit from hemodynamic support beyond the index procedure\n* Informed consent granted by the patient or legally authorized representative\n\nExclusion Criteria:\n\n* Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit\n* Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)\n* Aortic stenosis and\u002For aortic regurgitation categorized as moderate or greater (mean gradient \\>20 mmHg or valve area \\\u003C1.5 cm2 as assessed on TTE)\n* Presence of decompensated liver disease; severe liver dysfunction (Child-Pugh Score class C)\n* Ongoing renal replacement therapy with dialysis or continues renal replacement therapy\n* Heparin-induced thrombocytopenia, current or any prior occurrences\n* Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or known hypersensitivity to heparin, aspirin, adenosine diphosphate (ADP) receptor inhibitors, or nitinol\n* Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000\u002Fmm³ or spontaneous International Normalized Ratio (INR) ≥1.5 in the absence of medication or known fibrinogen ≤1.5 g\u002FL)\n* Breastfeeding or pregnant\n* Currently participating in active follow-up phase of another clinical study of an investigational drug or device\n* Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and\u002For to comply with study procedures",{"count":57,"type":22},45,[25],"The objective of this study is to assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular hemodynamic support beyond the PCI procedure.",[61,62,63],"Heart Disease","Coronary Arterial Disease (CAD)","Heart Failure",[65,34],"Percutanous ventricular assist device","2026-02-11",{"date":68,"type":40},"2026-02-17",{"date":70,"type":40},"2025-10-12",{"date":72,"type":22},"2027-05",{"name":46,"class":47},""]