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

May 5, 2016 updated by: Papworth Hospital NHS Foundation Trust

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?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambs
      • Cambridge, Cambs, United Kingdom, CB23 3RE
        • Recruiting
        • Papworth Hospital
        • Principal Investigator:
          • Stephen Large, FRCS
        • Principal Investigator:
          • P Catarino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients being referred to a specialist centre for diagnosis and treatment of their aneurysm

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Watchful Waiting
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)
Stenting (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.
Procedure: Stent Grafting (ESR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aneurysm Growth
Time Frame: 1, 2, 3 , 4 and 5 years post recruitment
1, 2, 3 , 4 and 5 years post recruitment
Quality of life
Time Frame: 1, 2, 3 , 4 and 5 years post recruitment
1, 2, 3 , 4 and 5 years post recruitment
Freedom from reintervention
Time Frame: 1, 2, 3 , 4 and 5 years post recruitment
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
1, 2, 3 , 4 and 5 years post recruitment
Costs to the NHS
Time Frame: 1, 2, 3 , 4 and 5 years post recruitment
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
1, 2, 3 , 4 and 5 years post recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papworth Hospital NHS Foundation Trust

Investigators

  • Study Chair: Stephen Large, FRCS, Papworth Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ANTICIPATED)

January 1, 2019

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (ESTIMATE)

December 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P01633
  • 11/147/03 (OTHER_GRANT: NIHR Health Technology Assessment Programme)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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