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

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ClinicalTrials.gov Identifier: NCT02010892
Recruitment Status : Recruiting
First Posted : December 13, 2013
Last Update Posted : May 6, 2016
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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?

Condition or disease Intervention/treatment
Thoracic Aortic Aneurysm Procedure: Stent Grafting (ESR) Procedure: Open Surgery (OSR)

Study Design
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Study Type : Observational
Estimated Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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U.S. FDA Resources

Groups and Cohorts
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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)


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Aneurysm Growth [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ]
  2. Quality of life [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ]
  3. Freedom from reintervention [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ]
  4. Freedom from death or permanent neurological injury [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ]
  5. Costs to the NHS [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ]
  6. Incremental cost per quality adjusted life year gained [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients being referred to a specialist centre for diagnosis and treatment of their aneurysm
Criteria

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)
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Contact: Vikki Hughes, PhD 01480 364821 victoria.hughes@papworth.nhs.uk

Locations
United Kingdom
Papworth Hospital Recruiting
Cambridge, Cambs, United Kingdom, CB23 3RE
Principal Investigator: Stephen Large, FRCS         
Principal Investigator: P Catarino         
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Investigators
Study Chair: Stephen Large, FRCS Papworth Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02010892     History of Changes
Other Study ID Numbers: P01633
11/147/03 ( Other Grant/Funding Number: NIHR Health Technology Assessment Programme )
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases