[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100468942":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":32,"locations":42,"responsibleParty":83,"collaborators":85,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":20,"enrollmentInfo":98,"targetDuration":20,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":20,"overallStatus":45,"whyStopped":20,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"LeMaitre Vascular","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"LeMaitre TufTex Over-the-Wire Embolectomy Catheter","OTHER","The LeMaitre Over the Wire Embolectomy Catherer is indicated for use in the removal of emboli and thrombi during embolectomy and\u002For thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and\u002For aspiration.",[13],"Device: TufTex Over-the-Wire Embolectomy Catheter",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","TufTex Over-the-Wire Embolectomy Catheter","The OTW Catheter can be used for the removal of emboli and thrombi. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and\u002For aspiration.",[9],null,[22,26,29],{"name":23,"affiliation":24,"role":25},"Giorgio Prouse, MD","Ospedale Regionale di Lugano - sede Civico","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":28,"role":25},"Andrej Udelnow, MD","University of Brandenburg",{"name":30,"affiliation":31,"role":25},"Sandra Korn, MD","University Hospital Carl Gustav Carus",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":20,"email":37},"Andrew Hodgkinson","CONTACT","781-425-1664","ahodgkinson@lemaitre.com",{"name":39,"role":35,"phone":40,"phoneExt":20,"email":41},"Brian Orrick","781-425-1685","borrick@lemaitre.com",[43,58,71],{"facility":44,"status":45,"city":46,"state":20,"zip":20,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Andrej Udelnow","RECRUITING","Brandenburg","Germany","DE",{"type":50,"coordinates":51},"Point",[52,53],6.14466,50.69716,{"lat":53,"lon":52},[56],{"name":44,"role":35,"phone":20,"phoneExt":20,"email":57},"a.udelnow@klinikum-brandenburg.de",{"facility":59,"status":60,"city":61,"state":20,"zip":20,"country":47,"countryCode":48,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"University Hospital Carl Gustav Carus TU Dresden","NOT_YET_RECRUITING","Dresden",{"type":50,"coordinates":63},[64,65],13.73832,51.05089,{"lat":65,"lon":64},[68],{"name":69,"role":35,"phone":20,"phoneExt":20,"email":70},"Sandra Korn","sandra.korn@uniklinikum-dresden.de",{"facility":24,"status":45,"city":72,"state":20,"zip":20,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Lugano","Switzerland","CH",{"type":50,"coordinates":76},[77,78],8.96004,46.01008,{"lat":78,"lon":77},[81],{"name":23,"role":35,"phone":20,"phoneExt":20,"email":82},"Giorgio.Prouse@eoc.ch",{"type":84,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[86],{"name":87,"class":6},"Avania","100468942","a-pmcf-study-confirm-the-performance-and-safety-of-the-tuftex-over-the-wire-otw-embolectomy-catheters-100468942",false,"NCT05386342","A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters","A Post-market Clinical Study to Confirm the Performance and Safety of the LeMaitre TufTex Over-the-Wire (OTW) Embolectomy Catheter on Patients Undergoing Surgical Treatment for the Removal of Arterial Emboli and\u002For Thrombi","OTW","Inclusion Criteria:\n\n1. Male and female subject, ≥ 18 years of age at time of enrollment.\n2. Subject who is scheduled to undergo surgical treatment for the removal of an emboli or thrombi during an embolectomy and\u002For thrombectomy procedure, where one of the LeMaitre® Embolectomy Catheter will be used.\n3. Subject signed an Informed Consent for participation.\n4. Subject diagnosed with a embolus\u002Fthrombus.\n5. Subjects for whom thrombolytic therapy had failed or was contraindicated.\n\nExclusion Criteria:\n\n1. Co-morbidity that in the discretion of the investigator might confound the results.\n2. Subjects who are unable to read or write.\n3. Pregnant or lactating women at time of enrollment\n4. Subjects who are immune compromised","ALL","18 Years",{"count":99,"type":100},112,"ESTIMATED","INTERVENTIONAL",[103],"NA","A PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter",[106,107,108],"Thrombus","Embolus","Occlusion; Vessel","2024-10-16",{"date":111,"type":112},"2024-10-18","ACTUAL",{"date":114,"type":112},"2023-01-11",{"date":116,"type":100},"2027-06",{"name":5,"class":6},3]