Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-10 @ 12:34 AM
Study NCT ID:
NCT04545502
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2020-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D000094628', 'term': 'Aortic Root Aneurysm'}, {'id': 'D000094630', 'term': 'Dissection, Ascending Aorta'}, {'id': 'D020212', 'term': 'Carotid Artery Injuries'}, {'id': 'D001018', 'term': 'Aortic Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017545', 'term': 'Aortic Aneurysm, Thoracic'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000094629', 'term': 'Dissection, Thoracic Aorta'}, {'id': 'D000784', 'term': 'Aortic Dissection'}, {'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020214', 'term': 'Cerebrovascular Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058017', 'term': 'Vascular Grafting'}], 'ancestors': [{'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2037-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2020-09-03', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative Death', 'timeFrame': '1 Year', 'description': '30 Day or In-Hospital Mortality'}, {'measure': 'Graft Leakage', 'timeFrame': '1 Year', 'description': 'Device Failure: The presence of leakage or excessive bleeding through graft/patch'}], 'secondaryOutcomes': [{'measure': 'Device Endpoints', 'timeFrame': '1 Year', 'description': 'Device failures, requirement for reintervention or device related adverse events'}, {'measure': 'Procedural Endpoints', 'timeFrame': '1 Year', 'description': 'Rifampicin or heparin soaking, procedure related adverse events'}, {'measure': 'Safety Endpoints', 'timeFrame': '1 Year', 'description': 'Occurrence of the following: Mortality, Ischemia, Occlusion, Thrombosis, Haemmorrhage, Rupture, Pseudoaneurysm, Stroke'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vascular Surgery'], 'conditions': ['Aneurysm', 'Dissection', 'Aortic Root Aneurysm', 'Aortic Root Dissection', 'Carotid Artery Injuries', 'Aortic Arch', 'Bypass Extremity Graft', 'Occlusive Vascular Disease', 'Aortic Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.\n\nData will be collected both retrospectively and prospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who require treatment, or have already received treatment within the last 5 years, with the following commercially available Terumo Aortic knitted and woven grafts and cardiovascular patches:\n\n* Gelsoft Plus - Straights and Bifurcated\n* Gelsoft Plus - Extra-Anatomical\n* Cardiovascular Patches - Gelseal, Gelsoft and Thin Wall\n* Gelweave - Abdominal, Thoracic and Thoracoabdominal\n* Gelweave - Valsalva This is a non-interventional study and therefore only patients who would normally receive treatment with a Terumo Aortic devices as part of standard treatment at the participating institution can be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must meet all of the following inclusion criteria in order to be eligible for inclusion in the study:\n\nAll Patients:\n\n* Patient meets the minimum age as per local regulations at time of consent\n* Patient requires treatment with study device(s) according to the IFU(s)\n* Patient is willing and able to comply with all SOC procedures and study visits\n* Patient or their legally authorised representative (LAR) has given written informed consent to participate in study, including consent to collect data retrospectively\n\n * For prospective emergency patients, retrospective consent is permissible\n * For retrospective patients who are deceased at time of enrollment, local EC regulations relating to consent process should be followed.\n\nRetrospective Patients only:\n\n* Patient has a minimum of 1 year post-operative follow-up data available, or complete data to death.\n* Patient implant date is no more than 5 years prior to study start date.\n\nExclusion Criteria:\n\n* Any patient who meets any of the following exclusion criteria will be excluded from participation in the study:\n\n * Patient is unable or unwilling to comply with the SOC procedures or follow-up regime\n * Patient is contraindicated per the device IFU\n * Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post-procedure'}, 'identificationModule': {'nctId': 'NCT04545502', 'acronym': 'PANTHER', 'briefTitle': 'PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vascutek Ltd.'}, 'officialTitle': 'A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches', 'orgStudyIdInfo': {'id': 'PANTHER-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gelsoft Plus - Straights and Bifurcated', 'description': 'Patients with aneurysmal or occlusive disease, including those with connective tissue disorders who have received/will receive a Gelsoft Plus Straight or Bifurcate, implanted in the abdomen or peripheral arteries in the last 5 years and from study launch onwards.', 'interventionNames': ['Device: Gelsoft Plus Vascular Graft']}, {'label': 'Gelsoft Plus - Extra-Anatomical', 'description': 'Any patients who have received/will receive a Gelsoft Plus Extra-Anatomical supported or unsupported graft, implanted for: axillary-femoral bypass, femoral-femoral bypass or femoral-popliteal bypass in the last 5 years and from study launch onwards.', 'interventionNames': ['Device: Vascular Bypass Graft']}, {'label': 'Cardiovascular Patches - Gelseal, Gelsoft, Thin Wall', 'description': 'Patients who have been implanted with/require a cardiovascular patch for: thoracic vessel repair with a Gelseal Cardiovascular Patch; abdominal or peripheral vessel repair with a Gelsoft Cardiovascular Patch; or carotid endarterectomy with a Thin Wall Carotid Patch in the last 5 years and from study launch onwards.', 'interventionNames': ['Device: Cardiovascular Patch']}, {'label': 'Gelweave - Abdominal, Thoracic, Thoracoabdominal', 'description': 'Patients who, due to either aneurysmal or occlusive disease, have had/require vascular repair of one of the following, implanted in the last 5 years and from study launch onwards:\n\n* Abdominal aorta, arteries arising from the abdominal aorta or peripheral arteries including femoral, iliac and popliteal arteries.\n* Thoracic aorta or arteries arising from the thoracic aorta.\n* Abdominal and thoracic aorta requiring a thoracoabdominal repair', 'interventionNames': ['Device: Gelweave Vascular Graft']}, {'label': 'Gelweave - Valsalva', 'description': 'Patients who have had/require aortic root repair using valve sparing or valve replacing procedures, with or without replacement of the aortic arch, implanted in the last 5 years and from study launch onwards.', 'interventionNames': ['Device: Gelweave Valsalva Vascular Graft']}], 'interventions': [{'name': 'Gelsoft Plus Vascular Graft', 'type': 'DEVICE', 'otherNames': ['Gelsoft Plus'], 'description': 'Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.', 'armGroupLabels': ['Gelsoft Plus - Straights and Bifurcated']}, {'name': 'Vascular Bypass Graft', 'type': 'DEVICE', 'otherNames': ['Gelsoft Plus Extra Anatomical'], 'description': 'Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.', 'armGroupLabels': ['Gelsoft Plus - Extra-Anatomical']}, {'name': 'Cardiovascular Patch', 'type': 'DEVICE', 'otherNames': ['Gelseal Patch', 'Gelsoft Patch', 'Thinwall Patch', 'Cardiovascular Fabrics'], 'description': 'Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.', 'armGroupLabels': ['Cardiovascular Patches - Gelseal, Gelsoft, Thin Wall']}, {'name': 'Gelweave Vascular Graft', 'type': 'DEVICE', 'otherNames': ['Gelweave'], 'description': 'The Gelweave woven polyester vascular graft allows replacement of large sections of arteries and, following anastomosis to the native blood vessel, provides a stable conduit for blood flow.', 'armGroupLabels': ['Gelweave - Abdominal, Thoracic, Thoracoabdominal']}, {'name': 'Gelweave Valsalva Vascular Graft', 'type': 'DEVICE', 'otherNames': ['Gelweave Valsalva'], 'description': 'This woven polyester graft is designed to match the aortic root anatomy and is implanted to repair or replace a portion of the aorta in case of an aneurysm, dissection or coarctation at the level of the thoracic aorta.', 'armGroupLabels': ['Gelweave - Valsalva']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brett Reece', 'role': 'CONTACT'}, {'name': 'Brett Reece', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado Anschutz', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33620', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thanh Tran', 'role': 'CONTACT', 'email': 'tqtran@usf.edu'}, {'name': 'Murray Shames', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of South Florida - Tampa General', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joel Corvera, MD', 'role': 'CONTACT', 'email': 'jcorvera@iuhealth.org'}, {'name': 'Joel Corvera', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indiana University Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chad Hughes', 'role': 'CONTACT', 'email': 'gchad.hughes@duke.edu'}, {'name': 'Chad Hughes', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27858', 'city': 'Greenville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eddie Hill', 'role': 'CONTACT', 'email': 'Hille19@ecu.edu'}, {'name': 'Benjamin Degner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Terence Semenec', 'role': 'CONTACT', 'email': 'terence.semenec@UHhospitals.org'}, {'name': 'Jae Cho', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 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'country': 'United States', 'contacts': [{'name': 'Daniel Newton, MD', 'role': 'CONTACT', 'email': 'daniel.newton@vcuhealth.org'}, {'name': 'Daniel Newton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Nathalie Moreels', 'role': 'CONTACT', 'email': 'nathalie.moreels@uzgent.be'}, {'name': 'Nathalie Moreels', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '8500', 'city': 'Kortrijk', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Philip Lerut', 'role': 'CONTACT', 'email': 'philip.lerut@azgroeninge.be'}, {'name': 'Philip Lerut', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AZ Groeninge Kortrijk', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Peter Verbrugghe', 'role': 'CONTACT', 'email': 'peter.verbrugghe@uzleuven.be'}, {'name': 'Peter Verbrugghe', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Tara Andrinopoulos', 'role': 'CONTACT', 'email': 'andrinopou@HHSC.CA'}, {'name': 'Theodore Rapanos', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hamilton General', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Bordeaux', 'status': 'WITHDRAWN', 'country': 'France', 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Valerie Batel', 'role': 'CONTACT', 'email': 'vbatel@chu-clermontferrand.fr'}, {'name': 'Thaveau', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU 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'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nabil Chakfe', 'role': 'CONTACT'}, {'name': 'Nabil Chakfe', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpitaux Universitaires de Strasbourg - Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier Chaufour', 'role': 'CONTACT'}, {'name': 'Xavier Chaufour', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Toulouse - Hôpital Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '12200', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Irene Hinterseher', 'role': 'CONTACT', 'email': 'gefaesschirurgie@charite.de'}, {'name': 'Irene Hinterseher', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charité Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53127', 'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marwan Hamiko', 'role': 'CONTACT', 'email': 'marwan.hamiko@ukbonn.de'}, {'name': 'Marwan Hamiko', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uniklinik Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Gabriele Lechner', 'role': 'CONTACT', 'email': 'gabriele.lechner@uniklinik-freiburg.de'}, {'name': 'Martin Czerny', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UNIVERSITÄTSKLINIKUM FREIBURG/Bad Krozingen', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '20251', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Sebastian Debus', 'role': 'CONTACT', 'email': 's.debus@uke.de'}, {'name': 'Sebastian Debus', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UKE Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Borger', 'role': 'CONTACT'}, {'name': 'Michael Borger', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Heart Center Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55131', 'city': 'Mainz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hazem El Beyrouti', 'role': 'CONTACT'}, {'name': 'Hazem El Beyrouti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsmedizin Mainz (University Hospital Mainz)', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '81377', 'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Joscha Buch', 'role': 'CONTACT', 'email': 'joscha.buech@med.uni-muenchen.de'}, {'name': 'Sven Peterss', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ludwig-Maximilian Universität (LMU) Klinikum', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '1122', 'city': 'Budapest', 'state': 'Budapest', 'status': 'COMPLETED', 'country': 'Hungary', 'facility': 'Semmelweis University Heart and Vascular Center', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4818', 'city': 'Breda', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'L. van der Laan, Prof. Dr.', 'role': 'CONTACT', 'email': 'lvanderlaan@amphia.nl'}, {'name': 'L. van der Laan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Amphia Hospital (Ziekenhuis) Breda', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}], 'centralContacts': [{'name': 'Clinical Study Manager', 'role': 'CONTACT', 'email': 'r.smith1@terumoaortic.com', 'phone': '+44 141 343 0194'}, {'name': 'TA UK Clinical Research', 'role': 'CONTACT', 'email': 'clinicalresearchuk@terumoaortic.com', 'phone': '+44 141 812 5555'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vascutek Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}