Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-04-18 @ 5:57 AM
Study NCT ID:
NCT02480595
Status:
SUSPENDED
Last Update Posted:
2021-11-01
First Post:
2015-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Recruitment on hold', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Success', 'timeFrame': '12 months', 'description': 'Defined as freedom from the following:\n\n* Sac expansion \\> 5mm\n* Type I and III endoleaks requiring re-intervention\n* Rupture\n* Conversion to open surgery\n* Stent graft migration \\> 10 mm\n* Stent graft occlusion'}], 'secondaryOutcomes': [{'measure': 'Graft Performance', 'timeFrame': '30 Days to 12 Months', 'description': 'Defined as:\n\n* Stent graft migration \\> 10mm (12 months)\n* Stent graft patency (12 months)\n* Stent graft endoleaks (30 days and 12 months)\n* Aneurysm-related secondary procedure (12 months)\n* Adverse device effects (12 months)\n* Technical observations (12 months)\n* Aneurysm-related mortality (12 Months)\n* All-cause mortality (30 days and 12 months)\n* Major Adverse Events (MAEs) (30 days)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Abdominal Aortic Aneurysm', 'AAA', 'Endovascular', 'EVAR', 'Stent', 'Stent Graft', 'High Angle', 'Tortuous'], 'conditions': ['Abdominal Aortic Aneurysms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lombardmedical.com', 'label': 'Lombard Medical Home Page'}]}, 'descriptionModule': {'briefSummary': 'The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective, registry designed to collect "on-label" data in real world clinical settings on patients undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft System. Registry data will augment existing data from ongoing and prospective Aorfix™ clinical trials for the purposes of publication, general product development and quality measures.', 'detailedDescription': 'The ARCHYTAS Registry is a long-term, global, multicenter, non-randomized, prospective, registry established by Lombard Medical Ltd. (Lombard) to collect "on-label" data in real world clinical settings on patients undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft System, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°. This indication for Aorfix™ is approved in all territories where this Registry is being operated and this Registry does not seek to collect data on any use of the implant for which full commercial approval does not already exist.\n\nThe ARCHYTAS Registry data will augment existing data from ongoing and prospective clinical trials with Aorfix™ for the purposes of publication, general product development and quality measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The ARCHYTAS Registry will meet objectives only if appropriate patients are enrolled. Patients presenting with AAA who fulfill inclusion criteria and are not ruled out by exclusion criteria will be included. Each investigator will record all potential participants screened for inclusion and document reasons for ineligibility. The implanting physician will consider all relevant medical and nonmedical factors when determining if a particular patient is suitable for inclusion in the Registry. In order to prevent selection bias, sites will be asked to screen and enroll patients consecutively. In circumstances where patients are screened and subsequently enrolled, but for various reasons are not implanted with the Aorfix™ device, only the screening and procedural data will be collected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed abdominal aortic aneurysm with indication for endovascular repair.\n2. Intention to electively implant the Aorfix™ Stent Graft System.\n\nExclusion Criteria:\n\n1. Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU).\n2. Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care at the investigative site.\n3. Unwillingness or inability to provide informed consent to both the Registry and the EVAR procedure.\n4. Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft.'}, 'identificationModule': {'nctId': 'NCT02480595', 'acronym': 'ARCHYTAS', 'briefTitle': 'AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lombard Medical'}, 'officialTitle': 'ARCHYTAS: AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft', 'orgStudyIdInfo': {'id': 'ARCHYTAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EVAR', 'description': 'Patients undergoing endovascular repair with the latest generation Aorfix™ AAA Flexible Stent Graft System for treatment of abdominal aortic and aorto-iliac aneurysms where the aorta in the aneurysm neck is bent through an angle between 0° and 90°', 'interventionNames': ['Device: Stent Graft']}], 'interventions': [{'name': 'Stent Graft', 'type': 'DEVICE', 'otherNames': ['Aorfix™ stent', 'Aorfix™ stent graft'], 'description': 'Endovascular repair of abdominal aortic aneurysm (EVAR)', 'armGroupLabels': ['EVAR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12808', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Prague University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinikum Herzzentrum Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45131', 'city': 'Essen', 'country': 'Germany', 'facility': 'Alfried Krupp Krankenhaus', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '45134', 'city': 'Essen', 'country': 'Germany', 'facility': 'Elisabeth-Krankenhaus Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'University Hospital Halle', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '65549', 'city': 'Limburg', 'country': 'Germany', 'facility': 'St.Vincenz-Krankenhaus Limburg', 'geoPoint': {'lat': 48.03138, 'lon': 12.18221}}, {'zip': '49808', 'city': 'Lingen', 'country': 'Germany', 'facility': 'Bonifatius Hospital', 'geoPoint': {'lat': 52.52143, 'lon': 7.31845}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum Rechts der Isar der TU München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '26655', 'city': 'Westerstede', 'country': 'Germany', 'facility': 'Ammerland Klinik GmbH', 'geoPoint': {'lat': 53.25682, 'lon': 7.92737}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '21100', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Ospedale Papa Giovanni 23', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '22020', 'city': 'Como', 'country': 'Italy', 'facility': "Sant'Anna", 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'zip': '26900', 'city': 'Lodi', 'country': 'Italy', 'facility': 'Ospeale Maggiore', 'geoPoint': {'lat': 45.30989, 'lon': 9.50085}}, {'zip': '06100', 'city': 'Perugia', 'country': 'Italy', 'facility': "Ospedale Sant'Andrea delle Fratte", 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Tor Vergata', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '20097', 'city': 'San Donato', 'country': 'Italy', 'facility': 'Policlinico San Donato IRCCS', 'geoPoint': {'lat': 45.08201, 'lon': 7.66485}}, {'zip': '1023', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '8036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'University Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '11009', 'city': 'Cadiz', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'facility': 'H. Universitari Dr. Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '18012', 'city': 'Granada', 'country': 'Spain', 'facility': 'University Hospital S. Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'HGU Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '32005', 'city': 'Ourense', 'country': 'Spain', 'facility': 'Complexo Hospitalario Universitario de Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'zip': '07120', 'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'H. Universitari Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '20014', 'city': 'San Sebastián', 'country': 'Spain', 'facility': 'Hospital Universitario Donostia', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'H. Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth General Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'BS10 5NB', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Southmead Hospital', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CM1 7ET', 'city': 'Chelmsford', 'country': 'United Kingdom', 'facility': 'Mid Essex Hospital - Broomfield', 'geoPoint': {'lat': 51.73575, 'lon': 0.46958}}, {'zip': 'HA1 3UJ', 'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Northwick Park Hospital', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Kings College Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NR4 7UY', 'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk & Norwich University Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'PR2 9HT', 'city': 'Preston', 'country': 'United Kingdom', 'facility': 'Royal Preston Hospital', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}], 'overallOfficials': [{'name': 'Vicente Riambau', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinic, Barcelona, Spain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lombard Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}