[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617768":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":40,"centralContacts":45,"locations":51,"responsibleParty":124,"collaborators":10,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":10,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":10,"enrollmentInfo":135,"targetDuration":10,"studyType":138,"phases":10,"briefSummary":139,"conditions":140,"keywords":10,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Intervascular","INDUSTRY",[8,16,19],{"label":9,"type":10,"description":10,"interventionNames":11},"Peripheral Arterial Disease (PAD) Cohort",null,[12,13,14,15],"Device: Intergard Standard - Collagen Coated Vascular Grafts and Patches","Device: Hemashield - Collagen Coated Vascular Grafts and Patches","Device: Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches","Device: Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts",{"label":17,"type":10,"description":10,"interventionNames":18},"Aortic Disease Cohort",[12,13,14,15],{"label":20,"type":10,"description":10,"interventionNames":21},"Carotid Artery Disease Cohort",[12,13],[23,28,32,36],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"DEVICE","Intergard Standard - Collagen Coated Vascular Grafts and Patches","Intergard Standard, Collagen coated vascular grafts and patches are made of knitted (knitted or knitted ultrathin) or woven polyester. The products are coated with a highly purified form of cross-linked bovine collagen to minimize intraoperative bleeding and eliminate the need for preclotting at the time of implant. Note that the radially supported grafts have a polypropylene supportive coil designed to resist kinking and compression of extra-anatomical vascular repair, where potential unwanted mechanical compression of the graft may occur.",[17,20,9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"Hemashield - Collagen Coated Vascular Grafts and Patches","Hemashield Vascular Grafts and Patches are made of knitted or woven polyester. The products are impregnated with a highly purified bovine collagen to reduce bleeding at the time of implant and thereby eliminates the operative preclotting step.",[17,20,9],{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"Intergard Silver - Antimicrobial Collagen Coated Vascular Grafts and Patches","Intergard Silver antimicrobial collagen coated vascular grafts are made of knitted (knitted or knitted ultrathin) or woven polyester. The Hemapatch Silver Ultrathin is a surgical patch made from knitted ultrathin polyester fabric. The products are coated with a highly purified form of cross-linked bovine collagen to minimize intraoperative bleeding and eliminate the need for preclotting at the time of implant. In addition to collagen coating, the collagen matrix of Intergard Silver vascular grafts and patches is loaded with an antimicrobial agent: silver acetate. The coating of silver is designed to inhibit the microbial colonization on the device and within tissue immediately proximate to the device in the acute post-operative phase.",[17,9],{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"Intergard Synergy - Antimicrobial Collagen Coated Vascular Grafts","Intergard Synergy antimicrobial collagen coated vascular grafts are made of knitted (knitted or knitted ultrathin) polyester. The products are coated with a highly purified form of cross-linked bovine collagen to minimize intraoperative bleeding and eliminate the need for preclotting at the time of implant.\n\nIn addition to collagen coating, the collagen matrix of Intergard Synergy Antimicrobial collagen coated vascular grafts is loaded with antimicrobial agents: silver acetate and triclosan. The addition of silver acetate and triclosan on collagen coated vascular products is designed to inhibit the microbial colonization on the device and in the surrounding tissues in the acute postoperative phase.",[17,9],[41],{"name":42,"affiliation":43,"role":44},"Director, Clinical Affairs","Getinge","STUDY_DIRECTOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":10,"email":50},"Senior Manager, Clinical Affairs","CONTACT","+1 603 233 7685","kristen.nolin@getinge.com",[52,74,90,107],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"The Pennsylvania State University and The Milton S. Hershey Medical Center","RECRUITING","Hershey","Pennsylvania","17033","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-76.65025,40.28592,{"lat":64,"lon":63},[67,71],{"name":68,"role":48,"phone":69,"phoneExt":10,"email":70},"Margaret McConnell","717-531-5966","mmcconnell2@pennstatehealth.psu.edu",{"name":72,"role":73,"phone":10,"phoneExt":10,"email":10},"Faisal Aziz","PRINCIPAL_INVESTIGATOR",{"facility":75,"status":54,"city":76,"state":56,"zip":77,"country":58,"countryCode":59,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Allegheny General Hospital","Pittsburgh","15212",{"type":61,"coordinates":79},[80,81],-79.99589,40.44062,{"lat":81,"lon":80},[84,88],{"name":85,"role":48,"phone":86,"phoneExt":10,"email":87},"Sheila Bernardini","412-359-3281","sheila.bernardini@AHN.org",{"name":89,"role":73,"phone":10,"phoneExt":10,"email":10},"Satish Muluk",{"facility":91,"status":54,"city":92,"state":10,"zip":10,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"CHU Dijon Bourgogne","Dijon","France","FR",{"type":61,"coordinates":96},[97,98],5.01391,47.31344,{"lat":98,"lon":97},[101,105],{"name":102,"role":48,"phone":103,"phoneExt":10,"email":104},"Aline Laubriet Jazayeri","03 80 28 12 94","aline.laubriet@chu-dijon.fr",{"name":106,"role":73,"phone":10,"phoneExt":10,"email":10},"Eric Steinmetz",{"facility":108,"status":54,"city":109,"state":10,"zip":10,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Hospital Universitario de Navarra","Pamplona","Spain","ES",{"type":61,"coordinates":113},[114,115],-1.64323,42.81687,{"lat":115,"lon":114},[118,122],{"name":119,"role":48,"phone":120,"phoneExt":10,"email":121},"Andrea Lombarte Serrat","+(34) 848 422 102","alombars@navarra.es",{"name":123,"role":73,"phone":10,"phoneExt":10,"email":10},"Esther Martinez Aguilar",{"type":125,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100617768","intervascular-post-market-clinical-follow-up-pmcf-registry-100617768",false,"NCT07322913","Intervascular Post-Market Clinical Follow-Up (PMCF) Registry","Post-Market Clinical Follow-up Registry to Evaluate the Safety and Performance of the Intervascular Vascular Grafts and Patches in Patients Undergoing Bypass, Replacement, or Repair of Aortic, Peripheral, or Carotid Arteries","Inclusion Criteria:\n\n* Willing, and able to provide legally-effective written informed consent (as required by Institutional Review Board or Ethics Committee)\n* Male and female patients that have undergone bypass, replacement or repair of the peripheral arteries, aorta, or carotid artery using the Intervascular Vascular Grafts and Patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy)\n* Were at least 18 years of age at the time of the procedure\n* Available records for data collection with a minimum of 3 years (36 months) of data\u002Ffollow-up.\n\nExclusion Criteria:\n\n* Active infection in the region of device placement at the time of implantation of the Intergard Standard and Hemashield Vascular Graft or Patch.","ALL","18 Years",{"count":136,"type":137},1200,"ESTIMATED","OBSERVATIONAL","The purpose of this registry is to evaluate the long-term safety and performance of Intervascular Vascular Grafts and Patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy) for bypass, repair or replacement of aortic, peripheral, or carotid arteries. This registry is intended to further define the expected product lifetime of the devices and to collect data related to usefulness of the antimicrobial coatings.",[141,142,143],"Carotid Artery Diseases","Aortic Diseases","Peripheral Arterial Diseases","2026-06-12",{"date":146,"type":147},"2026-06-15","ACTUAL",{"date":149,"type":147},"2025-12-19",{"date":151,"type":137},"2026-12",{"name":5,"class":6},4]