Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study

• Conditions: Thoracic Aortic Aneurysm
• Interventions: Procedure: Open Surgery (OSR); Procedure: Stent Grafting (ESR)

• Registration Number: NCT02010892
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

Brief Summary

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.

Aims

We aim to answer the following questions:

1. 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)?

2. 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?

3. How does QoL change from pre- to post intervention?

4. Can aneurysm or patient related predictors of good/poor treatment outcomes be determined?

5. What is the most cost-effective strategy in:

1. Patients eligible for either ESG or OSR?

2. Patients eligible for either ESG or best medical therapy (BMT)?

3. Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)?

6. What further research is required? What would be the most important research to pursue?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-13
• Study Start: 2014-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-05
• Last Update Posted: 2016-05-06
• Primary Completion: 2019-01
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

• Thoracic Aortic Aneurysm > 4cm
• Age ≥18 years
• Able to give informed consent

Exclusion Criteria

• Intervention required below the level of the coeliac axis
• Acute dissection or malperfusion syndromes (such as myocardial infarction,acute stroke or limb ischaemia)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open Surgery (OSR)	Open Surgery (OSR)	Replacement of the aneurysmal aorta with prosthetic conduit via a sternotomy or thoracotomy with circulatory support.
Stenting (ESR)	Stent Grafting (ESR)	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.

Primary Outcome Measures

Name	Time	Method
Freedom from reintervention	1, 2, 3 , 4 and 5 years post recruitment
Costs to the NHS	1, 2, 3 , 4 and 5 years post recruitment
Quality of life	1, 2, 3 , 4 and 5 years post recruitment
Incremental cost per quality adjusted life year gained	1, 2, 3 , 4 and 5 years post recruitment
Aneurysm Growth	1, 2, 3 , 4 and 5 years post recruitment
Freedom from death or permanent neurological injury	1, 2, 3 , 4 and 5 years post recruitment

Trial Locations

Locations (1)

Papworth Hospital; 🇬🇧 Cambridge, Cambs, United Kingdom