Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study
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.
We aim to answer the following questions:
- 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)?
- 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?
- How does QoL change from pre- to post intervention?
- Can aneurysm or patient related predictors of good/poor treatment outcomes be determined?
What is the most cost-effective strategy in:
- Patients eligible for either ESG or OSR?
- Patients eligible for either ESG or best medical therapy (BMT)?
- Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)?
- What further research is required? What would be the most important research to pursue?
Thoracic Aortic Aneurysm
Procedure: Stenting (ESR)
Procedure: Open Surgery (OSR)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study|
- Aneurysm Growth [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ] [ Designated as safety issue: No ]
- Freedom from reintervention [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ] [ Designated as safety issue: No ]
- Freedom from death or permanent neurological injury [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ] [ Designated as safety issue: No ]
- Costs to the NHS [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ] [ Designated as safety issue: No ]
- Incremental cost per quality adjusted life year gained [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ] [ Designated as safety issue: No ]
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||July 2019|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
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.
Best Medical Therapy
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.
Open Surgery (OSR)
Replacement of the aneurysmal aorta with prosthetic conduit via a sternotomy or thoracotomy with circulatory support.
|Procedure: Open Surgery (OSR)|
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.
|Procedure: Stenting (ESR)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02010892
|Contact: Vikki Hughes, PhD||01480 email@example.com|
|Cambridge, Cambs, United Kingdom, CB23 3RE|
|Principal Investigator: Stephen Large, FRCS|
|Principal Investigator: P Catarino|
|Study Chair:||Stephen Large, FRCS||Papworth Hospital|