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Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study (ETTAA)
This study is currently recruiting participants.
Verified May 2016 by Papworth Hospital NHS Foundation Trust
Sponsor:
Papworth Hospital NHS Foundation Trust
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
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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:
- 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)?
- 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?
- How does QoL change from pre- to post intervention?
- Can aneurysm or patient related predictors of good/poor treatment outcomes be determined?
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What is the most cost-effective strategy in:
- Patients eligible for either ESG or OSR?
- Patients eligible for either ESG or best medical therapy (BMT)?
- Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)?
- 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:
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 ]
- Quality of life [ Time Frame: 1, 2, 3 , 4 and 5 years post recruitment ]
- Freedom from reintervention [ Time Frame: 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 ]
- Costs to the NHS [ Time Frame: 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 ]
| 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 |
|---|---|
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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.
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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.
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Open Surgery (OSR)
Replacement of the aneurysmal aorta with prosthetic conduit via a sternotomy or thoracotomy with circulatory support.
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Procedure: Open Surgery (OSR) |
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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) |
| 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
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
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 ( Other Grant/Funding Number: NIHR Health Technology Assessment Programme ) |
| Study First Received: | November 22, 2013 |
| Last Updated: | May 5, 2016 |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on August 17, 2017