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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Papworth Hospital NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT02010892
First received: November 22, 2013
Last updated: May 5, 2016
Last verified: May 2016
History of Changes
  Purpose

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 Intervention
Thoracic Aortic Aneurysm
 Procedure: Stent Grafting (ESR)
Procedure: Open Surgery (OSR)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Papworth Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Aneurysm Growth [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ] [ Designated as safety issue: No ]
  • Freedom from reintervention [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ] [ Designated as safety issue: No ]
  • Freedom from death or permanent neurological injury [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ] [ Designated as safety issue: No ]
  • Costs to the NHS [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ] [ Designated as safety issue: No ]
  • Incremental cost per quality adjusted life year gained [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ] [ Designated as safety issue: No ]
Estimated Enrollment: 2200
Study Start Date: February 2014
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02010892     History of Changes
Other Study ID Numbers: P01633  11/147/03 
Study First Received: November 22, 2013
Last Updated: May 5, 2016
Health Authority: United Kingdom: National Institute for Health Research

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

ClinicalTrials.gov processed this record on September 27, 2016