Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-02 @ 5:53 AM
Study NCT ID:
NCT00522535
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2007-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2007-08-27', 'studyFirstSubmitQcDate': '2007-08-28', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aorfix™ vs. Open Control All Cause Mortality', 'timeFrame': '1 year', 'description': 'The 12 month, all cause mortality rate in the Aorfix™ group compared to all cause mortality rate in the Open Control group.'}], 'secondaryOutcomes': [{'measure': 'Aorfix™ vs. Open Control Adverse Events', 'timeFrame': '30 days', 'description': 'The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups compared to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AAA', 'Abdominal Aortic Aneurysms', 'Endovascular', 'EVAR', 'Aorta', 'Stent Graft', 'Stent', 'Tortuous', 'High Angle', 'Angled Necks'], 'conditions': ['Abdominal Aortic Aneurysms']}, 'referencesModule': {'references': [{'pmid': '28943010', 'type': 'DERIVED', 'citation': 'Wang S, Hicks CW, Malas MB. Neck diameter and inner curve seal zone predict endograft-related complications in highly angulated necks after endovascular aneurysm repair using the Aorfix endograft. J Vasc Surg. 2018 Mar;67(3):760-769. doi: 10.1016/j.jvs.2017.07.114. Epub 2017 Sep 21.'}, {'pmid': '28190716', 'type': 'DERIVED', 'citation': 'Malas MB, Hicks CW, Jordan WD Jr, Hodgson KJ, Mills JL Sr, Makaroun MS, Belkin M, Fillinger MF; PYTHAGORAS Investigators. Five-year outcomes of the PYTHAGORAS U.S. clinical trial of the Aorfix endograft for endovascular aneurysm repair in patients with highly angulated aortic necks. J Vasc Surg. 2017 Jun;65(6):1598-1607. doi: 10.1016/j.jvs.2016.10.120. Epub 2017 Feb 9.'}, {'pmid': '26321596', 'type': 'DERIVED', 'citation': 'Malas MB, Jordan WD, Cooper MA, Qazi U, Beck AW, Belkin M, Robinson W, Fillinger M. Performance of the Aorfix endograft in severely angulated proximal necks in the PYTHAGORAS United States clinical trial. J Vasc Surg. 2015 Nov;62(5):1108-17. doi: 10.1016/j.jvs.2015.05.042. Epub 2015 Aug 28.'}], 'seeAlsoLinks': [{'url': 'http://www.lombardmedical.com', 'label': 'Lombard Medical Technologies Inc. Homepage'}]}, 'descriptionModule': {'briefSummary': 'Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac aneurysms with anatomies including angled aorta, angled aneurysmal body, or both, between 0° and 90°.\n\nStudy hypothesis: The primary efficacy hypothesis is the proportion of grafts remaining free from endoleak, migration, and fracture at 12 months.\n\nEfficacy: The 12 month, all cause mortality rate in the Aorfix™ group will be non-inferior to the 12 month, all cause mortality rate in the Open Control group.\n\nSafety: The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix™ groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed abdominal aortic aneurysm \\> 4.5 cm in diameter, OR 4.0 cm or larger in diameter if symptomatic (i.e. pain, embolization), OR documented AAA growth of more than 5 mm within the previous 6 months, and/or including extension into common iliac artery (ies), and/or\n* Iliac aneurysm greater than, or equal to 3.5 cm in maximum diameter.\n\nExclusion Criteria:\n\n* Less than 21 years of age,\n* Life expectancy less than 2 years,\n* Pregnant,\n* Religious cultural or other objection to the receipt of blood or blood products,\n* Unwilling to comply with follow-up schedule,\n* Unwillingness or inability to provide informed consent to both trial and procedure.\n* Patients not expected to live more than 2 years from enrollment\n* Patient has a ruptured aneurysm\n* Aneurysm extends above renal arteries\n* Proximal neck of aneurysm has significant loose thrombus associated with it\n* Patient with an acute or chronic aortic dissection or mycotic aneurysm\n* Patient has current non-localized infection (may be recruited following remission of the infection)\n* Patient is allergic to device materials\n* Patient is allergic to or intolerant of use of contrast media and cannot be exposed to suitable remedial treatment such as steroids and/or benadryl\n* Patient is clinically and morbidly obese such that imaging would be severely adversely affected\n* Patient has renal failure (serum creatinine \\> 2.5 mg/dL)\n* Patient has an uncorrectable bleeding abnormality\n* Patient has unstable angina\n* Patient is receiving dialysis:\n* Inflammatory aneurysm\n* MI in last 6 months\n* End stage COPD\n* Patient has connective tissue disease (eg Marfan syndrome, Ehlers-Danlos syndrome)\n* Significant (\\>80%) renal artery stenosis which cannot be readily treated'}, 'identificationModule': {'nctId': 'NCT00522535', 'acronym': 'PYTHAGORAS', 'briefTitle': 'Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lombard Medical'}, 'officialTitle': 'Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft', 'orgStudyIdInfo': {'id': 'PYTHAGORAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Open Surgical Repair', 'description': 'Open surgical repair of abdominal aortic aneurysm. All patient enrollment and 2-year follow-ups completed.', 'interventionNames': ['Procedure: Open surgical repair']}, {'type': 'EXPERIMENTAL', 'label': 'Endovascular Repair', 'description': 'Endovascular treatment arm of 160 patients having suitable anatomy for the Aorfix™ AAA Flexible Stent Graft System. Use of stent grafts in aortic angles greater than 60° has not been approved for other devices available in the US. As a result, a minimum of 120 patients in this arm will have an aortic angle between 60° and 90°.\n\nPatient recruitment completed; 5-year follow-up evaluations continue.', 'interventionNames': ['Device: Stent Graft']}, {'type': 'EXPERIMENTAL', 'label': 'Continued Access', 'description': 'Endovascular treatment arm of 50 patients maximum having suitable anatomy for the Aorfix™ AAA Flexible Stent Graft System. This Arm will provide active sites with ongoing device access while FDA reviews the PMA.\n\nPatient recruitment completed; 5-year patient follow-ups continue.', 'interventionNames': ['Device: Stent Graft']}], 'interventions': [{'name': 'Open surgical repair', 'type': 'PROCEDURE', 'description': 'Open surgical repair of abdominal aortic aneurysm', 'armGroupLabels': ['Open Surgical Repair']}, {'name': 'Stent Graft', 'type': 'DEVICE', 'otherNames': ['Aorfix™ stent graft', 'Aorfix™ AAA stent graft'], 'description': 'Endovascular repair of abdominal aortic aneurysm (EVAR)', 'armGroupLabels': ['Continued Access', 'Endovascular Repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Vascular Surgery', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona, Department of Surgery', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach VA Healthcare System', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Division of Vascular Surgery', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Hospital', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Hospital, Jim Moran Heart & Vascular Research Institute', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32610-0128', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Hospital of Miami, Cardiac & Vascular Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '31201', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Macon Cardiovascular Institute', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '61606', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Methodist Heart Lung & Vascular Institute', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Springfield Memorial Hospital', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'John Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan, Department of Vascular Surgery', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48507', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Vascular Group', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott Northwestern / MHIF', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth - Hitchcock Medical', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Englewood Hospital & Medical Center', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}, {'zip': '07112', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Newark-Beth Israel Medical Center', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian-Columbia University Medical Center Division of Vascular Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Jobst Vascular Center', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '17110', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pinnacle Health Hospitals', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '17043', 'city': 'Wormleysburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Moffitt Heart and Vascular Group', 'geoPoint': {'lat': 40.26287, 'lon': -76.91386}}, {'zip': '57117', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Sanford Clinic Clinical Research', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'DeBakey Heart Center, Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Heart Hospital - Vascular & Transplant Specialists', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Sacred Heart Medical Center', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin School of Medicine & Public Health', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Mark Fillinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lombard Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}