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

Thoracic Aortic Aneurysm Clinical Trial

— ETTAA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02010892
• Other study ID #: P01633
• Secondary ID: 11/147/03
• Status: Recruiting
• Phase: N/A
• First received: November 22, 2013
• Last updated: May 5, 2016
• Start date: February 2014
• Est. completion date: July 2019

Study information

• Verified date: May 2016
• Source: Papworth Hospital NHS Foundation Trust
• Contact: Vikki Hughes, PhD
• Phone: 01480 364821
• Email: victoria.hughes[@]papworth.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: July 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Thoracic Aortic Aneurysm

Intervention

Procedure:
• Stent Grafting (ESR)

• Open Surgery (OSR)

Locations

Country	Name	City	State
United Kingdom	Papworth Hospital	Cambridge	Cambs

Sponsors (1)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aneurysm Growth		1, 2, 3 , 4 and 5 years post recruitment	No
Primary	Quality of life		1, 2, 3 , 4 and 5 years post recruitment	No
Primary	Freedom from reintervention		1, 2, 3 , 4 and 5 years post recruitment	No
Primary	Freedom from death or permanent neurological injury		1, 2, 3 , 4 and 5 years post recruitment	No
Primary	Costs to the NHS		1, 2, 3 , 4 and 5 years post recruitment	No
Primary	Incremental cost per quality adjusted life year gained		1, 2, 3 , 4 and 5 years post recruitment	No