[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100485418":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":19,"responsibleParty":35,"collaborators":19,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":19,"maxAge":19,"enrollmentInfo":46,"targetDuration":19,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":19,"overallStatus":55,"whyStopped":19,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":19},{"fullName":5,"class":6},"SurModics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pounce Venous Thrombectomy System","OTHER","Subjects admitted for endovascular thrombus removal using the Pounce Venous Thrombectomy System",[13],"Device: Pounce Venous Thrombectomy System",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","The device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Michael Lichtenberg, MD","Klinikum Hochsauerland GmbH","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Nusrath Sultana, MD","CONTACT","763-777-2737","nsultana@surmodics.com",{"name":32,"role":28,"phone":33,"phoneExt":19,"email":34},"Aliza Avalos","209-485-2072","aavalos@surmodics.com",{"type":36,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100485418","surmodics-pounce-venous-thrombectomy-system-post-market-clinical-follow-up-study-100485418",false,"NCT05600816","SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study","CHOMP: SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study","CHOMP","Inclusion Criteria:\n\n1. Individuals aged 18 years or older\n2. Patients with peripheral vascular thrombus (e.g., iliofemoral) as confirmed by Doppler Ultrasonography (DUS)\n3. Voluntary informed written consent, given before performance of any clinical investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care\n4. Patients who would likely experience benefit from mechanical thrombus removal\n\nExclusion Criteria:\n\n1. Presence of a stent in the target vein\n2. Known aggressive hypercoagulable states such as antiphospholipid antibody syndrome, Protein C\u002FS Deficiency, Antithrombin deficiency, homozygous prothrombin gene mutation or homozygous Factor V Leiden\n3. Limb-threatening circulatory compromise\n4. Known symptomatic Pulmonary Embolism at the time of enrollment with or without severe RV dysfunction\n5. Patients with a positive COVID test result at the time of the procedure\n6. Patients who, according to the investigator, have a venous thrombus that may be associated with a prior COVID infection\n7. History of, or active heparin induced thrombocytopenia (HIT)\n8. Inability to withstand endovascular procedures\n9. Life expectancy \\\u003C 1 year\n10. Participation in any other drug or device studies that have not reached the primary endpoint follow up, which could compromise the results of either trial\n11. Patient has any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol\n12. Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel\n13. Known or suspected abuse of alcohol, narcotics or non-prescription drugs that would jeopardize study outcomes in the Investigator's opinion\n14. Inability to provide informed consent or to comply with study assessments (e.g., due to cognitive impairment or geographic distance)","ALL",{"count":47,"type":48},40,"ESTIMATED","INTERVENTIONAL",[51],"NA","This is an open label, prospective, non-randomised, multi-centre post market study of the POUNCE Venous Thrombectomy system for de-clotting in the peripheral vasculature (e.g., iliofemoral veins).",[54],"Peripheral Vascular Occlusive Disease","NOT_YET_RECRUITING","2024-05-07",{"date":58,"type":59},"2024-05-08","ACTUAL",{"date":61,"type":48},"2025-04-01",{"date":63,"type":48},"2026-10-01",{"name":5,"class":6}]