Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02010892
Status:
UNKNOWN
Last Update Posted:
2016-05-06
First Post:
2013-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061887', 'term': 'Conversion to Open Surgery'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-05', 'studyFirstSubmitDate': '2013-11-22', 'studyFirstSubmitQcDate': '2013-12-09', 'lastUpdatePostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aneurysm Growth', 'timeFrame': '1, 2, 3 , 4 and 5 years post recruitment'}, {'measure': 'Quality of life', 'timeFrame': '1, 2, 3 , 4 and 5 years post recruitment'}, {'measure': 'Freedom from reintervention', 'timeFrame': '1, 2, 3 , 4 and 5 years post recruitment'}, {'measure': 'Freedom from death or permanent neurological injury', 'timeFrame': '1, 2, 3 , 4 and 5 years post recruitment'}, {'measure': 'Costs to the NHS', 'timeFrame': '1, 2, 3 , 4 and 5 years post recruitment'}, {'measure': 'Incremental cost per quality adjusted life year gained', 'timeFrame': '1, 2, 3 , 4 and 5 years post recruitment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Thoracic Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '35094747', 'type': 'DERIVED', 'citation': 'Sharples L, Sastry P, Freeman C, Gray J, McCarthy A, Chiu YD, Bicknell C, McMeekin P, Vallabhaneni SR, Cook A, Vale L, Large S. Endovascular stent grafting and open surgical replacement for chronic thoracic aortic aneurysms: a systematic review and prospective cohort study. Health Technol Assess. 2022 Jan;26(6):1-166. doi: 10.3310/ABUT7744.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective observational cohort study that will collect data from the point of referral through to secondary care, aiming for 3 years median follow-up (range 1-5 years). The data collected will allow estimation of the success of any intervention (in terms of reducing rate of aneurysm growth, rupture or dissection) as well as estimation of the risks associated with the three procedures. Clinical outcomes in the three treatment groups will be described.\n\nAims\n\nWe aim to answer the following questions:\n\n1. Without procedural intervention for chronic thoracic aortic aneurysm (CTAA), what is the risk of aneurysm growth, dissection, rupture, permanent neurological injury or death? What is the effect on quality of life (QoL)?\n2. If a patient has endovascular stent grafting (ESG) or open surgical repair (OSR), what is the risk of growth, dissection, rupture, permanent neurological injury or death?\n3. How does QoL change from pre- to post intervention?\n4. Can aneurysm or patient related predictors of good/poor treatment outcomes be determined?\n5. What is the most cost-effective strategy in:\n\n 1. Patients eligible for either ESG or OSR?\n 2. Patients eligible for either ESG or best medical therapy (BMT)?\n 3. Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)?\n6. What further research is required? What would be the most important research to pursue?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients being referred to a specialist centre for diagnosis and treatment of their aneurysm', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thoracic Aortic Aneurysm \\> 4cm\n* Age ≥18 years\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Intervention required below the level of the coeliac axis\n* Acute dissection or malperfusion syndromes (such as myocardial infarction,acute stroke or limb ischaemia)'}, 'identificationModule': {'nctId': 'NCT02010892', 'acronym': 'ETTAA', 'briefTitle': 'Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Papworth Hospital NHS Foundation Trust'}, 'officialTitle': 'Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'P01633'}, 'secondaryIdInfos': [{'id': '11/147/03', 'type': 'OTHER_GRANT', 'domain': 'NIHR Health Technology Assessment Programme'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Watchful Waiting', 'description': "Patients with aneurysms considered to be at low risk of rupture will remain under surveillance with annual CT / MRI scans and multi-disciplinary team review (as per local practice). These patients' data will contribute to the natural history component of the study."}, {'label': 'Best Medical Therapy', 'description': 'This refers to lifestyle modification (smoking cessation and dietary management) as well as medical management of hypercholesterolaemia and hypertension for patients who are considered unsuitable for, or who refuse, OSR / ESG.'}, {'label': 'Open Surgery (OSR)', 'description': 'Replacement of the aneurysmal aorta with prosthetic conduit via a sternotomy or thoracotomy with circulatory support.', 'interventionNames': ['Procedure: Open Surgery (OSR)']}, {'label': 'Stenting (ESR)', 'description': 'Endovascular repair of the aneurysm via transluminal introduction of a stent-graft under X-ray guidance. Hybrid procedures that comprise a combination of a conventional surgical component and a transluminal repair are to be included in this group.', 'interventionNames': ['Procedure: Stent Grafting (ESR)']}], 'interventions': [{'name': 'Stent Grafting (ESR)', 'type': 'PROCEDURE', 'armGroupLabels': ['Stenting (ESR)']}, {'name': 'Open Surgery (OSR)', 'type': 'PROCEDURE', 'armGroupLabels': ['Open Surgery (OSR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB23 3RE', 'city': 'Cambridge', 'state': 'Cambs', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Stephen Large, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'P Catarino', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Papworth Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'centralContacts': [{'name': 'Vikki Hughes, PhD', 'role': 'CONTACT', 'email': 'victoria.hughes@papworth.nhs.uk', 'phone': '01480 364821'}], 'overallOfficials': [{'name': 'Stephen Large, FRCS', 'role': 'STUDY_CHAIR', 'affiliation': 'Papworth Hospital NHS Foundation Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Papworth Hospital NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}