[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559949":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":42,"responsibleParty":55,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":86,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Clinical Centre of Serbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IOPS group",null,"Patients with AAA undergoing standard EVAR according to the IFU using IOPS technology for visulisation of guidewires and catheter for the cannulation of contralateral limb.",[13],"Device: Intra-Operative Positioning System (IOPS)",{"label":15,"type":10,"description":16,"interventionNames":17},"Conventional group","Patients with AAA undergoing standard EVAR according to the IFU using standardised approach and materials.",[18],"Device: Conventional group",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","Intra-Operative Positioning System (IOPS)","This medical device provides surgeons with 3D visualization for increased surgical precision while reducing the use of contrast dye and radiation exposure for patients and healthcare professionals alike. IOPS provides 3D electromagnetic navigation of interventional devices as an adjunct to fluoroscopy. During the intervention, the IOPS devices can be visualized with on-screen image guidance. The console is operated by a technician under a physician's instruction. The IOPS guidewires and catheters can be used together or combined with off-the-shelf 0.035-inch catheters and guidewires, as needed.",[9],{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":10},"This group will be treated using standardised materials (wires, catheters) during EVAR.",[15],[29],{"name":30,"affiliation":31,"role":32},"Igor Koncar, MD PhD","University Clinical Centre of Serbia","STUDY_CHAIR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Petar Zlatanovic, MD PhD FEBVS","CONTACT","+381668300278","petar91goldy@gmail.com",{"name":30,"role":36,"phone":40,"phoneExt":10,"email":41},"+381668300290","dr.koncar@gmail.com",[43],{"facility":44,"status":10,"city":45,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":10},"Clinical Center of Serbia","Belgrade","11000","Serbia","RS",{"type":50,"coordinates":51},"Point",[52,53],20.46513,44.80401,{"lat":53,"lon":52},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Petar Zlatanovic","Principal Investigator MD PhD FEBVS",[60],{"name":61,"class":62},"Centerline Biomedical, Inc.","INDUSTRY","100559949","iops-technology-during-cannnulation-of-contralateral-limb-in-evar-100559949",false,"NCT06570785","IOPS Technology During Cannnulation of Contralateral Limb in EVAR","Contralateral Limb Cannulation Using Intra-Operative Positioning SystemTechnology in Endovascular Aneurysm Repair","IOPS","Inclusion Criteria:\n\n\\- All patients (over 18 years of age) with infrarenal AAA treated between 1st September 2024 and 1st May 2025 undergoing standard EVAR according to the IFU\n\nExclusion Criteria:\n\n* Patients who are pregnant\n* Patients who are under 40 years of age\n* Patients who have symptomatic or ruptured AAA\n* Patients with more advanced AAA: juxtarenal, pararenal, suprarenal, thoracic, thoracoabdominal AAA\n* Non-atherosclerotic origin of disease: dissection, connective tissue disorders, mycotic AAA, posttraumatic AAA\n* Patients who were treated in a conservative manner\n* Patients undergoing open surgery\n* Patients undergoing more advanced treatment options: fenestrated\u002Fbranched EVAR, endostaplers, chimney EVAR, iliac branch devices, etc.","ALL","40 Years","100 Years",{"count":75,"type":76},80,"ESTIMATED","OBSERVATIONAL","Short-term results are favorable for EndoVascular Aneurysm Repair (EVAR) compared to open surgery. One of the major drawbacks to this shift is the need for fluoroscopy and contrast dyes to visualise endovascular devices. The use of fluoroscopy exposes both patients and caregivers to harmful ionizing radiation. Because of the harmful effects of radiation, recent radiation protection guidelines strongly recommend as low as reasonably achievable (ALARA) principle. The need for additional radiation-reducing navigation techniques is high, with the ultimate goal of performing endovascular procedures without radiation at all.\n\nIn response to these challenges, Centerline Biomedical (Cleveland, Ohio, USA) has developed a proprietary electromagnetic tracking and positioning system called the Intra-Operative Positioning System (IOPS). This medical device provides surgeons with 3D visualization for increased surgical precision while reducing the radiation exposure for patients and healthcare professionals. IOPS provides 3D electromagnetic navigation of interventional devices as an adjunct to fluoroscopy. During the intervention, the IOPS devices can be visualized with on-screen image guidance. The IOPS guidewires and catheters can be used together or combined with off-the-shelf 0.035-inch catheters and guidewires, as needed.\n\nThis study aims to describe the influence of IOPS technology on radiation exposure during cannulation of the contralateral limb (CL) during standard EVAR.",[80,81,82],"Abdominal Aortic Aneurysm","Abdominal Aortic Aneurysm Without Rupture","Radiation Exposure",[80,84,85],"EndoVascular Aneurysm Repair","Radiation Protection","NOT_YET_RECRUITING","2024-11-17",{"date":89,"type":90},"2024-11-20","ACTUAL",{"date":92,"type":76},"2025-01-20",{"date":94,"type":76},"2025-11-03",{"name":5,"class":6},1]