[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Humacyte, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,72],{"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":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"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":19,"type":20},125,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Vascular Injury","Arterial Injury","Trauma Injury",[30,31,32,33,34,35],"Trauma","Extremity arterial injury","Symvess","Arterial injury","Vascular injury","Trauma injury","NOT_YET_RECRUITING","2026-08-11",{"date":39,"type":40},"2026-08-13","ACTUAL",{"date":42,"type":20},"2026-09",{"date":44,"type":20},"2030-09",{"name":46,"class":47},"Humacyte, Inc.","INDUSTRY",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100651687","phase-3-an-open-label-study-to-assess-the-safety-and-efficacy-of-symvess-as-a-vascular-conduit-in-adolescents-with-extremity-arterial-injury-100651687","NCT07762313","An Open-label Study to Assess the Safety and Efficacy of SYMVESS® as a Vascular Conduit in Adolescents With Extremity Arterial Injury.","A Prospective, Multi-center, Open-label Study, to Assess the Safety and Efficacy of SYMVESS® as a Vascular Conduit in Adolescents With Extremity Arterial Injury When Autologous Vein Graft is Not Feasible.","Inclusion Criteria:\n\n1. Patients 17 years of age or younger who have reached adult sexual maturity (i.e., Tanner Sexual Maturity Rating Stage 5) as determined by the Investigator\n\n   a. For purposes of this study, Tanner Stage 5 is defined for both males and females as having pubic hair that extends beyond the inguinal crease onto the thigh\n2. Patients with extremity arterial injury requiring urgent revascularization to avoid imminent limb loss\n3. Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6mm SYMVESS per the judgment of the treating surgeon, taking into account vasoconstriction and situational inflow and outflow considerations\n4. Autologous vein graft is either not feasible, in the judgment of the treating surgeon (e.g. because of lack of availability of suitable conduit) or is not desirable because of the urgency of revascularization\n5. Patient and parent\u002Flegal representative are able to communicate meaningfully with investigative staff and able to comply with study procedures and visits.\n6. Patient is able and willing to provide informed assent and parent (or legal representative) is able and willing to provide informed consent prior to treatment with SYMVESS\n7. Life expectancy of at least 1 year based on clinical assessment by the Investigator\n\nExclusion Criteria:\n\n1. Limb at high risk of amputation despite vascular reconstruction evidenced by Mangled Extremity Severity Score (MESS) of ≥ 7\n2. Injury Severity Score (ISS) \\>60\n3. Known pregnant females\n4. Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries\n5. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SYMVESS\n6. Previous exposure to SYMVESS\n7. Known participation in any investigational study within the last 30 days\n8. Employees of the sponsor or patients who are employees or relatives of the Investigator","17 Years",{"count":57,"type":20},10,[59],"PHASE3","The goal of this study is to assess the safety and efficacy of Symvess in sexually mature adolescents (17 years of age or younger) who require a vascular conduit to repair an extremity arterial injury when autologous vein graft is not available.\n\nThe main questions the study aims to answer are:\n\nSafety and tolerability of Symvess in adolescent patients? Determine patency of Symvess over 12-months Evaluate the long-term amputation-free rate Determine the ability of Symvess to remain infection-free\n\nParticipants will undergo implantation of Symvess to repair an arterial injury in an extremity using standard surgical techniques. Following implantation, patients will be followed for up to 12-months where they will undergo standard safety assessments, patency assessments using Duplex Ultrasound, and examination of the surgical site.",[62,27,63],"Vascular Trauma","Arterial Bleeding",[32,30,65,33],"Adolescents","2026-08-07",{"date":39,"type":40},{"date":42,"type":20},{"date":70,"type":20},"2028-12",{"name":46,"class":47},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":94,"leadSponsor":95,"locationsCount":4},"100649214","phase-2-study-to-evaluate-the-safety-and-efficacy-of-humacytes-coronary-tissue-engineered-vessel-ctev-in-patients-with-coronary-artery-disease-requiring-coronary-artery-bypass-grafting-cabg-100649214","NCT07730528","Study to Evaluate the Safety and Efficacy of Humacyte's Coronary Tissue Engineered Vessel (CTEV) in Patients With Coronary Artery Disease Requiring Coronary Artery Bypass Grafting (CABG)","A Phase 2a Study for the Evaluation of Safety and Efficacy of Humacyte's Coronary Tissue Engineered Vessel (CTEV) as a Vascular Conduit for Coronary Artery Bypass Grafting in Patients With Coronary Artery Disease","Inclusion Criteria:\n\n1. Age ≥18 years with the ability to provide written informed consent.\n2. Planned first isolated CABG surgery for atherosclerotic coronary artery disease with a planned LIMA graft to the LAD and at least one other planned vessel bypass.\n3. An RCA or LCx territory target vessel for the CTEV graft with the following characteristics:\n\n   1. Target vessel stenosis of ≥80% (including total occlusion) or a fraction flow reserve (FFR) of ≤0.8.\n   2. Good target vessel quality with a diameter of at least 2.5 mm.\n   3. Good target vessel run-off as determined by the Investigator.\n\nExclusion Criteria:\n\n1. Recent (within 7 days) acute myocardial infarction.\n2. Hemodynamic instability or need for emergent CABG surgery.\n3. Acute heart failure or abnormal left ventricular wall motion (e.g., ejection fraction \\\u003C55%).\n4. Ascending aortic pathology, including aneurysm, dissection, or significant calcification.\n5. Prior cardiac surgery.\n6. Planned concomitant valve or aortic surgery.\n7. Known bleeding disorder or thrombophilia.\n\n   1. Thrombocytopenia (platelet count \\\u003C100 x 109\u002FL)\n   2. Clinically significant anemia (hemoglobin \\\u003C9.0 g\u002FdL)\n   3. Elevated prothrombin time (INR \\> 1.3) or partial thromboplastin time (\\>35 seconds) not due to anticoagulation therapy.\n8. Required post-operative anticoagulation therapy.\n9. Known or suspected allergies or contraindications to aspirin or clopidogrel, heparin, or contrast agents that cannot be adequately pre-treated.\n10. Chronic kidney disease with eGFR \\\u003C 45 ml\u002Fmin\u002F1.73 m2).\n11. Previous exposure to the Humacyte ATEV (Symvess).\n12. Use of any investigational drug or device within 60 days.\n13. Women of childbearing potential defined as not sterile or not at least 1 year postmenopausal.\n14. Any condition, including active substance abuse, that in the opinion of the investigator, prevents participants from following the protocol, including the planned CT angiographic follow-up through at least 12-14 months.\n15. Active infection requiring ongoing antibiotic therapy or conditions that would increase the risk of infection or other complications evidenced by the following:\n\n    1. Compromised immune function from medication or underlying disease\n    2. Clinically significant low white blood cell count (leukopenia)\n    3. Uncontrolled diabetes mellitus (HbgA1c \\>8.0%, serum glucose \\>300 mg\u002FdL)\n    4. Active malignancy.\n16. Clinically significant hepatic cirrhosis or dysfunction evident by any of the following laboratory abnormalities:\n\n    1. AST or ALT ≥3x ULN\n    2. low serum albumin \\\u003C 2.0 g\u002FdL\n    3. high bilirubin \\> 2 mg\u002FdL)\n17. Participants who are considered not suitable for on-pump CABG procedure.",{"count":57,"type":20},[81],"PHASE2","The goal of this study is to assess safety and efficacy of Humacyte's coronary tissue engineered vessel (CTEV) used as a bypass conduit in patients requiring multi vessel coronary artery bypass grafting (CABG).\n\nThe main question it aims to answer whether the CTEV is feasible as a conduit in CABG surgery.\n\nEach participant will be implanted with a CTEV using standard surgical techniques and followed for up to 36 months for routine assessments, including imaging, physical and clinical examinations, vital signs, laboratory assessments, and safety assessments.",[84],"Coronary Artery Disease",[86,87,88,89],"Coronary Artery Bypass Grafting","CTEV","Tissue Engineered Vessel","CABG","2026-07-23",{"date":92,"type":40},"2026-07-28",{"date":42,"type":20},{"date":44,"type":20},{"name":46,"class":47},""]