[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"TripleMed B.V.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100386151","aneufix---prophylactic-sac-filling-100386151",false,"NCT04307992","AneuFix - Prophylactic Sac Filling","Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation","Inclusion Criteria:\n\n* Asymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of Guntner et al:\n\n  \\- Open IMA AND\n  * 1 patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) \\>17,5cm2 OR\n  * 2 patent lumbars AND a CSAIMA \\>15cm2 OR\n  * 3 patent lumbars AND a CSAIMA \\>12,5 cm2 OR\n  * 4 patent lumbars AND a CSAIMA \\>10 cm2 OR\n  * 5 patent lumbars AND a CSAIMA \\>7,5 cm2\n* Infrarenal neck according to the IFU of the EVAR device\n* Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the EVAR device to be used\n* Patient having a life expectation of at least 2 years\n* Being older than 18 years\n* Willing and able to comply with the requirements of this clinical study\n\nExclusion Criteria:\n\n* Patient not able or willing to give written Informed Consent\n* Patient undergoing emergency procedures\n* Patient undergoing EVAR for ruptured or symptomatic AAA,\n* Patient with a suprarenal AAA\n* Patient with an inflammatory AAA (more than minimal wall thickening)\n* Patient with an infrarenal neck unsuitable for endovascular fixation (including so called \"hostile necks\") or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used\n* Patient in which a bilateral retroperitoneal incision is required for EVAR\n* Patient in which a sacrifice of both hypogastric arteries is required\n* Patient with anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation\n* Patient in which the administration of contrast agent is not possible: proved, severe systemic reaction to contrast agent\n* Patient with active infection present\n* Patients scheduled for or having received an organ transplant\n* Patient with limited life expectation due to other illness (\\\u003C1 year)\n* Patient with non-iatrogenic bleeding diathesis\n* Patient with connective tissue disease\n* Women of child-bearing potential\n* Patients with evidence at completion angiogram during EVAR of a type Ia or type III endoleak persistent after balloon inflation","ALL","18 Years",{"count":19,"type":20},5,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.",[26,27],"Abdominal Aortic Aneurysm","Endoleak","RECRUITING","2024-06-06",{"date":31,"type":32},"2024-06-07","ACTUAL",{"date":34,"type":32},"2022-02-15",{"date":36,"type":20},"2025-12-31",{"name":38,"class":39},"TripleMed B.V.","INDUSTRY",""]