[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651572":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":22,"responsibleParty":29,"collaborators":22,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":22,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":22,"enrollmentInfo":40,"targetDuration":22,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":51,"overallStatus":57,"whyStopped":22,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":22},{"fullName":5,"class":6},"Humacyte, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Symvess","OTHER","Symvess will be surgically implanted in accordance with the approved USPI for patients with extremity vascular injury",[13],"Biological: Acellular Tissue Engineered Vessel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Acellular Tissue Engineered Vessel","Humacyte Acellular Tissue Engineered Vessel, marketed under the name Symvess",[9],[21,9],"ATEV",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Warren Prosser","CONTACT","919-313-9633","wprosser@humacyte.com",{"type":30,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100651572","phase-4-multicenter-study-to-evaluate-the-safety-and-efficacy-of-symvess-in-a-real-world-setting-in-patients-with-extremity-arterial-injury-requiring-urgent-repair-100651572",false,"NCT07762794","Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting in Patients With Extremity Arterial Injury Requiring Urgent Repair","A Phase 4 Observational Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting for Arterial Replacement or Reconstruction in Patients With Extremity Vascular Trauma","Inclusion Criteria:\n\n1. Aged at least 18 years old\n2. Patient is suitable to be implanted with a Symvess for extremity vascular trauma, in accordance with the approved indication of the USPI\n\n   1. Symvess implant is to be used to re-establish blood flow to one of the major extremity arteries (see Section 4.1 for examples of size appropriate vessels)\n   2. Although the proximal anastomosis may originate in the upper or lower torso region, the distal anastomosis must terminate in the extremity (e.g., below the inguinal crease for lower extremity, in the axillary or more distal in the upper extremity)\n3. Patient or legal representative is able, willing, and competent to give informed consent.\n4. Patient's life expectancy is at least 1 year based on the judgement of the Investigator\n5. Patient must have a home or place of residence whereby he\u002Fshe may be contacted and a support system which would make them suitable for this study of one year follow-up duration\n6. Patient must have confirmed health insurance\n\nExclusion Criteria:\n\n1. Limb at a high risk of amputation due to nature of the initial injury in the judgement of the Investigator, despite adequate revascularization\n2. Patients lacking enough healthy muscle and\u002For soft tissue for adequate coverage of Symvess\n3. Known drug or alcohol abuse that in the opinion of the Investigator would preclude the patient from being suitable for long-term follow-up\n\n   a. Positive screen for illicit drugs (THC use is not exclusionary)\n4. Patient with known coagulopathies or hypercoagulable states (bleeding or clotting disorders)\n5. Known socioeconomic reasons (such as being homeless) that preclude the patient from being suitable for long-term follow-up\n6. Employee of the Sponsor or patient who is an employee or relative of the Investigator","ALL","18 Years",{"count":41,"type":42},125,"ESTIMATED","INTERVENTIONAL",[45],"PHASE4","The goal of this post-marketing observational study is to further assess the long-term safety and efficacy of Symvess in a real-world setting in adult patients with extremity arterial injury.\n\nThe primary objective of the study is to determine Symvess secondary patency at 1 year.\n\nAdditional key secondary objectives, such as limb salvage, infection-free rate, primary patency, and safety, will also be assessed at 1 year.\n\nAll participants will receive Symvess. This is an open-label study and there is no comparator.\n\nParticipants will undergo surgery to repair an extremity arterial injury using Symvess. Participants will be asked to return at regular intervals up to 1 year post-implant to undergo imaging to assess Symvess patency, and for other standard clinical safety and efficacy assessments.",[48,49,50],"Vascular Injury","Arterial Injury","Trauma Injury",[52,53,9,54,55,56],"Trauma","Extremity arterial injury","Arterial injury","Vascular injury","Trauma injury","NOT_YET_RECRUITING","2026-08-11",{"date":60,"type":61},"2026-08-13","ACTUAL",{"date":63,"type":42},"2026-09",{"date":65,"type":42},"2030-09",{"name":5,"class":6}]