Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT07147569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2025-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TAMBE Japan Post-Marketing Surveillance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094624', 'term': 'Aortic Aneurysm, Thoracoabdominal'}], 'ancestors': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '60 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2034-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2034-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Success', 'timeFrame': 'From the initial incision or puncture of the access vessel for the implantation procedure to the closure of the access vessel', 'description': 'Calculate the rate of achievement of technical success at the index procedure. The technical success is defined as follows.\n\n\\[Technical success\\]\n\nAll of the following qualifying criteria are met:\n\n* Successful access to the access vessels\n* Successful delivery and deployment of AC and all stent grafts used in combination with AC to its intended location\n* Successful side branch delivery catheterization and placement of all stent grafts used in the side branch area to its intended location\n* Absence of type I or type III endoleaks at final completion image evaluation\n* Patency of AC and all stent grafts used in combination with AC at final completion image evaluation\n* Absence of open surgical repair conversion or mortality'}, {'measure': 'Clinical Success', 'timeFrame': '12 Months', 'description': 'The achievement rate of clinical success will be calculated. The clinical success is defined as follows.\n\n\\[Clinical Success\\]\n\n* Achievement of technical success\n* Absence of the events listed below from the time of the index procedure to 12 months after the index procedure\n\n 1. Death from the index procedure\n 2. Death from reintervention\n 3. Death from aorta-related causes\n 4. Persistent type I or type III endoleaks\n 5. Lesion enlargement \\>5 mm\n 6. Device migration \\>10 mm\n 7. Failure due to device integrity issues\n 8. Lesion rupture\n 9. Conversion to open surgical repair\n 10. Permanent paraplegia\n 11. Disabling stroke\n 12. New-onset dialysis'}, {'measure': 'Results related to abdominal branch vessels', 'timeFrame': '60 Months', 'description': 'Calculate the incidence of the following events related to abdominal branch vessels (celiac artery, superior mesenteric artery, left/ right renal arteries) or AC and stent grafts used in combination with AC for visceral branch vessels.\n\n* Primary Patency\n* Primary Assisted Patency\n* Secondary Patency\n* Occlusion\n* Stenosis\n* Kink\n* Target vessel instability\n* Intraprocedural Complications'}, {'measure': 'Major Adverse Events (MAEs)', 'timeFrame': '60 Months', 'description': 'The incidence of any of following events is calculated.\n\n* All-cause mortality\n* Myocardial infarction resulting in death, cardiac arrest, or cardiopulmonary resuscitation\n* Respiratory failure requiring prolonged (\\> 24 hours) mechanical ventilation or reintubation\n* Renal function decline characterized by one or more of the following:\n\n 1. \\> 50% reduction in pre-treatment Estimated Glomerular Filtration Rate (eGFR)\n 2. New-onset dialysis\n* Bowel ischemia requiring surgical resection or not resolving with medical therapy\n* Permanent paraplegia\n* Major stroke (Any fatal or disabling stroke).'}, {'measure': 'Thirty-Day Mortality', 'timeFrame': '30 Days', 'description': 'Calculate thirty-day mortality. Thirty-day mortality is defined as follows.\n\n\\[Thirty-Day Mortality\\]\n\nAny death that occurs at the index procedure, within the index procedure hospital stay, or within the first 30 days post-index procedure.'}, {'measure': 'Lesion-Related Mortality', 'timeFrame': '30 Days', 'description': 'Calculate lesion-related mortality. Lesion-related mortality is defined as follows.\n\n\\[Lesion-related mortality\\]\n\nAny death that occurs within the first 30 days, any death that results from lesion rupture, aorta-related adverse events (e.g., infection, occlusion, dissection, hematoma), or adverse events related to a secondary intervention.'}, {'measure': 'Reintervention', 'timeFrame': '60 Months', 'description': 'Calculate the incidence of reintervention. Reintervention will be classified as "major" or "minor". Reintervention and its classifications are defined as follows.\n\n\\[Reintervention\\]\n\nAny procedure after the index procedure on the AC and stent grafts used in combination with AC.\n\n\\[Major Reintervention\\]\n\nDeployment the stent graft for proximal or distal side, removal of AC and stent grafts used in combination with AC, use of thrombectomy or thrombolysis, and surgical procedure.\n\n\\[Minor Reintervention\\]\n\nTreatment other than major reintervention that falls under any of the following categories\n\n* Endovascular procedures (percutaneous transluminal angioplasty, atherectomy, stenting)\n* Interventions to treat branch vessel stenosis\n* Interventions to treat type II endoleaks or branch-related endoleaks.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Thoracoabdominal Aortic Aneurysm', 'Pararenal Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target patients are those who were attempted to implant the AC during the enrollment period of this surveillance. Patients will also be targeted even if all components of the TAMBE device (devices that can be used in combination with AC specified in IFU) were not used, or if a device other than the component of the TAMBE device was used.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were attempted to implant the AC\n* Thoracoabdominal aortic aneurysm\n* Pararenal abdominal aortic aneurysm\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT07147569', 'briefTitle': 'TAMBE Japan Post-Marketing Surveillance', 'organization': {'class': 'INDUSTRY', 'fullName': 'W.L.Gore & Associates'}, 'officialTitle': 'GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Marketing Surveillance', 'orgStudyIdInfo': {'id': 'JPS 25-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAMBE', 'interventionNames': ['Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis']}], 'interventions': [{'name': 'GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis', 'type': 'DEVICE', 'description': 'The target patients are those who were attempted to implant the AC during the enrollment period of this surveillance. Patients will also be targeted even if all components of the TAMBE device (devices that can be used in combination with AC specified in IFU) were not used, or if a device other than the component of the TAMBE device was used.', 'armGroupLabels': ['TAMBE']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CMIC Co, Ltd. Japan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}