Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-09 @ 8:02 AM
Study NCT ID:
NCT02816333
Status:
WITHDRAWN
Last Update Posted:
2018-06-21
First Post:
2016-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Korean Registry of Thoracic Endovascular Aortic Repair Timing for Type B Aortic Dissection (K-TEAM Study): A Prospective Multicenter Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Due to the withdrawal of Gore Korea Co.Ltd., manufacturer of medical device, it is impossible to supply the medical device(C-TAG).', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-19', 'studyFirstSubmitDate': '2016-06-23', 'studyFirstSubmitQcDate': '2016-06-23', 'lastUpdatePostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse event', 'timeFrame': '12 months', 'description': 'A composite of all-cause death, re-intervention, and aortic dilation \\> 5 mm in maximal aortic diameter'}], 'secondaryOutcomes': [{'measure': 'Aortic remodeling', 'timeFrame': '12 months', 'description': 'Change in maximal aorta, true lumen, and false lumen dimensions'}, {'measure': 'Aorta-related complications', 'timeFrame': '12 months', 'description': 'composite events of aortic rupture, stroke, spinal chord ischemia, retrograde dissection, endoleaks, aortic dilation \\> 5mm in diameter'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type B Aortic Dissection']}, 'descriptionModule': {'briefSummary': 'Prospective, single-arm, multi-center registry study A total of 50 subjects with Type B aortic dissection who meet all inclusion and exclusion criteria will be included.\n\nPatients will be treated with TEVAR using conformable TAG endograft (Gore). Patients will be followed clinically for 12 months after the procedure. CT will be performed at 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Type B aortic dissection requiring thoracic endovascular aortic repair', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. a) In case of acute Type B dissection (14 days from first dissection)\n\n * Maximum aortic diameter \\>40 mm or\n * Increase in aortic diameter \\>2 mm from baseline b) In case of subacute (15\\~90 days) or chronic (90 days \\~ 1 year) Type B\n * Maximum aortic diameter \\>55 mm or\n * Increase in aortic diameter \\>4 mm from baseline\n2. Age 19-80 years.\n3. Aorta anatomy appropriate for stent graft therapy,\n\n 1. Proximal landing zone (diameters between 23 and 42 mm) is not aneurysmal, dissected or significantly thrombosed.\n 2. Proximal landing zone length \\>20 mm (length from the left subclavian artery origin to the primary intima tear or length from the left common carotid artery origin to the primary intima tear when the left subclavian artery is embolized and possibly revascularized), as measured from the outer curve of the aorta.\n4. Declaration of voluntary participation in the study with signed informed consent form.\n\nExclusion Criteria:\n\n1. Endorgan ischemia or evidence of malperfusion due to aortic dissection\n2. Aortic rupture or impeding rupture due to aortic dissection\n3. Renal dysfunction with serum Cr level \\>2.0 mg/dL\n4. Marfan syndrome, Loeys-Diets, Ehlers-Danlos syndrome, or other connective tissue diseases\n5. Uncontrolled active infection or active vasculitis.\n6. Recent myocardial infarction or cerebrovascular accident within 4 weeks prior to study enrollment.\n7. Previous thoracic aorta surgery or stent-graft implantation\n8. Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment.\n9. Women with positive pregnancy test or at child bearing age\n10. Life expectancy \\<1 year due to comorbidity'}, 'identificationModule': {'nctId': 'NCT02816333', 'briefTitle': 'Korean Registry of Thoracic Endovascular Aortic Repair Timing for Type B Aortic Dissection (K-TEAM Study): A Prospective Multicenter Registry', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '1-2016-0003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type B aortic dissection', 'description': 'Patients with Type B aortic dissection requiring TEVAR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan to share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}