Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-27 @ 8:53 AM
Study NCT ID:
NCT00590759
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2007-12-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017545', 'term': 'Aortic Aneurysm, Thoracic'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rmakowsk@wlgore.com', 'phone': '6232345784', 'title': 'Robert Makowsky', 'organization': 'W. L. Gore and Associates, Inc.'}, 'certainAgreement': {'otherDetails': 'Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Total Study Follow-up.', 'description': 'Note - the severity of adverse events (serious vs non-serious) was not collected, so all events, regardless of whether they would be classified as serious or not, are reported under "Other adverse events"', 'eventGroups': [{'id': 'EG000', 'title': '0502 TAG Device Subjects', 'otherNumAtRisk': 150, 'otherNumAffected': 147, 'seriousNumAtRisk': 150, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bleeding Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 52}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Cardiac Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 64}], 'organSystem': 'Cardiac disorders'}, {'term': 'Bowel Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Additional Implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 16}], 'organSystem': 'General disorders'}, {'term': 'Other Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 102}], 'organSystem': 'General disorders'}, {'term': 'Endoleak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 58}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Wound Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 43}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 15}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Neurologic Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 62}], 'organSystem': 'Nervous system disorders'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 40}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal Function Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 26}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Pulmonary Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 67}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Vascular Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 56}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Aneurysm Related Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thoracic Endograft', 'description': 'GORE TAG® Thoracic Endoprosthesis: implant'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Freedom from aneurysm related mortality for TAG 05-02 subjects', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thoracic Endograft', 'description': 'GORE TAG® Thoracic Endoprosthesis: implant'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Proportion of subjects in TAG 05-02 with MAEs', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Thoracic Endograft', 'description': 'GORE TAG® Thoracic Endoprosthesis: implant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Thoracic Endograft', 'description': 'GORE TAG® Thoracic Endoprosthesis: implant'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.1', 'spread': '10.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '102', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-06', 'studyFirstSubmitDate': '2007-12-20', 'resultsFirstSubmitDate': '2014-06-10', 'studyFirstSubmitQcDate': '2008-01-10', 'lastUpdatePostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-06', 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aneurysm Related Death', 'timeFrame': '5 years', 'description': 'Freedom from aneurysm related mortality for TAG 05-02 subjects'}], 'secondaryOutcomes': [{'measure': 'A Subset of Major Adverse Events Will be Evaluated in Subjects Treated With the TAG Device and Subjects Treated With Open Surgical Repair.', 'timeFrame': '5 years', 'description': 'Proportion of subjects in TAG 05-02 with MAEs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aortic Aneurysm, Thoracic']}, 'descriptionModule': {'briefSummary': 'The purpose of this post-approval study is to evaluate the long-term performance of the GORE TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic aortic (DTA) aneurysms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Descending thoracic aortic aneurysm deemed to warrant surgical repair:\n\n 1. Fusiform aneurysm greater than or equal to 2 times diameter of normal adjacent aorta\n 2. Saccular aneurysm\n2. Anatomy meets GORE TAG Thoracic Endoprosthesis specification criteria as indicated in the Instructions for Use (Appendix A)\n3. Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm\n\n • \\<60 degree angle in the aortic arch may require additional length of non-aneurysmal segment if the arch is included in the treatment segment\n4. Life expectancy \\> 2 years\n5. Surgical Candidate\n\n * ASA Class I, II, III, or IV\n * NYHA Class I, II, III or no heart disease\n6. Male or infertile female\n7. Minimum 21 years of age\n8. Able to comply with protocol requirements\n9. Signed Informed Consent Form\n\nExclusion Criteria:\n\n1. 4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta\n2. Significant thrombus at the proximal or distal implantation zones\n3. Mycotic aneurysm\n4. Hemodynamically unstable aneurysm rupture (non-contained aneurysm rupture)\n5. Acute or chronic aortic dissection\n6. Planned occlusion of the left carotid or celiac arteries\n7. "Planned" concomitant surgical procedure (other than left subclavian transposition) or previous major surgery within 30 days\n8. Myocardial infarction or cerebral vascular accident within 6 weeks\n9. Severe respiratory insufficiency sufficient that precludes open thoracotomy\n10. Renal insufficiency (Creatinine \\> 2.0 mg/dL) with or without dialysis\n11. Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome\n12. Participation in another investigational device or drug study within 1 year\n13. Documented history of drug abuse within 6 months'}, 'identificationModule': {'nctId': 'NCT00590759', 'briefTitle': 'Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms', 'organization': {'class': 'INDUSTRY', 'fullName': 'W.L.Gore & Associates'}, 'officialTitle': 'A Clinical Evaluation of the GORE TAG Thoracic Endoprosthesis in the Primary Treatment of Descending Thoracic Aortic Aneurysms', 'orgStudyIdInfo': {'id': 'TAG 05-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'GORE TAG® Thoracic Endoprosthesis', 'interventionNames': ['Device: GORE TAG® Thoracic Endoprosthesis']}], 'interventions': [{'name': 'GORE TAG® Thoracic Endoprosthesis', 'type': 'DEVICE', 'description': 'implant', 'armGroupLabels': ['GORE TAG® Thoracic Endoprosthesis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Greeley', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 40.42331, 'lon': -104.70913}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Albany', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}], 'overallOfficials': [{'name': 'Mark Morasch, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Vincent's Healthcare, Billings MT"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}