Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study (ETTAA)
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|ClinicalTrials.gov Identifier: NCT02010892|
Recruitment Status : Unknown
Verified May 2016 by Papworth Hospital NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : December 13, 2013
Last Update Posted : May 6, 2016
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?
|Condition or disease||Intervention/treatment|
|Thoracic Aortic Aneurysm||Procedure: Stent Grafting (ESR) Procedure: Open Surgery (OSR)|
|Study Type :||Observational|
|Estimated Enrollment :||2200 participants|
|Official Title:||Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||July 2019|
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: Stent Grafting (ESR)
- Aneurysm Growth [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ]
- Quality of life [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ]
- Freedom from reintervention [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ]
- Freedom from death or permanent neurological injury [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ]
- Costs to the NHS [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ]
- Incremental cost per quality adjusted life year gained [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010892
|Contact: Vikki Hughes, PhD||01480 firstname.lastname@example.org|
|Cambridge, Cambs, United Kingdom, CB23 3RE|
|Principal Investigator: Stephen Large, FRCS|
|Principal Investigator: P Catarino|
|Study Chair:||Stephen Large, FRCS||Papworth Hospital|