Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-31 @ 3:05 PM
Study NCT ID:
NCT05873959
Status:
COMPLETED
Last Update Posted:
2024-11-25
First Post:
2023-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study to Evaluate the Safety and Efficacy of Humacyte's HAV for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000081084', 'term': 'Accidental Injuries'}, {'id': 'D009104', 'term': 'Multiple Trauma'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03631056', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2023-05-16', 'studyFirstSubmitQcDate': '2023-05-16', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of the HAV', 'timeFrame': 'up to 12 months', 'description': 'To determine the rate of adverse events after impanation'}, {'measure': 'Primary patency of the HAV after implantation', 'timeFrame': '30 days', 'description': 'To determine the rate of HAV primary patency at 30 days after implantation'}], 'secondaryOutcomes': [{'measure': 'Frequency of Adverse Events of Special Interest (AESIs)', 'timeFrame': 'up to 12 months', 'description': 'To determine the rate of Adverse Events of Special Interest (AESIs), such as: thrombosis, clinically significant aneurysm or pseudoaneurysm formation, HAV spontaneous rupture, infection of the HAV conduit, and HAV abandonment.'}, {'measure': 'HAV durability', 'timeFrame': 'up to 12 months', 'description': 'To determine the time frame when the HAV has not been removed, replaced, or ligated.'}, {'measure': 'Rate of affected limb salvage/amputation after implantation', 'timeFrame': 'up to 12 months', 'description': 'To determine the rate of affected limb salvage/amputation after HAV implantation'}, {'measure': 'Patency of the HAV after implantation', 'timeFrame': 'up to 12 months', 'description': 'To determine the rate of HAV patency (primary, primary assisted, and secondary) after implantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['extremities', 'arterial replacement', 'arterial reconstruction'], 'conditions': ['Trauma', 'Trauma Injury', 'Trauma, Multiple', 'Trauma Blunt']}, 'referencesModule': {'references': [{'pmid': '37213923', 'type': 'BACKGROUND', 'citation': 'Sokolov O, Shaprynskyi V, Skupyy O, Stanko O, Yurets S, Yurkova Y, Niklason LE. Use of bioengineered human acellular vessels to treat traumatic injuries in the Ukraine-Russia conflict. Lancet Reg Health Eur. 2023 May 6;29:100650. doi: 10.1016/j.lanepe.2023.100650. eCollection 2023 Jun. No abstract available.'}, {'pmid': '39565635', 'type': 'RESULT', 'citation': 'Moore EE, Curi M, Namias N, Kundi R, Lum YW, Fox CJ, Rajani RR, Rasmussen TE, Sokolov O, Niklason LE, Khondker Z, Parikh SJ; CLN-PRO-V005 Investigators and the CLN-PRO-V017 Investigators. Bioengineered Human Arteries for the Repair of Vascular Injuries. JAMA Surg. 2025 Feb 1;160(2):181-189. doi: 10.1001/jamasurg.2024.4893.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.lanepe.2023.100650', 'label': 'Lancet Regional Health Europe'}]}, 'descriptionModule': {'briefSummary': 'Humacyte provided HAVs as humanitarian aid to Ukraine. This retrospective observational study is designed to collect data from patients in whom the HAVs have already been implanted on a humanitarian basis between June 2022 and May 2023.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with vascular trauma in the extremities who required arterial replacement or reconstruction and in whom the HAVs have been already implanted on a humanitarian basis between June 2022 and May 2023.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an HAV implanted to repair or reconstruct an arterial vessel following life- or limb-threatening traumatic vascular injury of an extremity.\n* Aged 18 to 85 years old, inclusive.\n* Patient or legal representative is able, willing, and competent to give informed consent.\n\nExclusion Criteria:\n\n• Employees of the sponsor or patients who are employees or relatives of the investigator.'}, 'identificationModule': {'nctId': 'NCT05873959', 'briefTitle': "An Observational Study to Evaluate the Safety and Efficacy of Humacyte's HAV for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma", 'organization': {'class': 'INDUSTRY', 'fullName': 'Humacyte, Inc.'}, 'officialTitle': "An Observational Multicenter Study to Evaluate the Safety and Efficacy of Humacyte's Human Acellular Vessel in a Real World Setting for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma", 'orgStudyIdInfo': {'id': 'CLN-PRO-V017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HAV implantation', 'type': 'BIOLOGICAL', 'description': 'HAVs already implanted under humanitarian aid program to repair or reconstruct arteries following an extremity life- or limb-threatening traumatic injury.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dnipro', 'country': 'Ukraine', 'facility': 'Municipal Non-Profit Enterprise ""City Clinical Hospital #16" of the Dnipro City Council"', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Medical Center LLC "CLINIC VERUM EXPERT"', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'city': 'Vinnytsia', 'country': 'Ukraine', 'facility': 'Communal non-profit enterprise "Vinnytsia Regional Clinical Hospital named after E. Pirogov" of the Vinnytsia Regional Council, center of cardiovascular surgery', 'geoPoint': {'lat': 49.2322, 'lon': 28.46871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humacyte, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}