Thoracic Aortic AneurysmETTAANCT02010892
Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study
An observational study of Thoracic Aortic Aneurysm, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysm
- What is being tested?
- Stent Grafting (ESR) and Open Surgery (OSR)
- Type of treatment
- Surgery or procedure
- How many people
- 2,200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being referred to a specialist centre for diagnosis and treatment of their aneurysm
Who may be able to join
- Thoracic Aortic Aneurysm > 4cm
- Age ≥18 years
- Able to give informed consent
Who cannot join
- Intervention required below the level of the coeliac axis
- Acute dissection or malperfusion syndromes (such as myocardial infarction,acute stroke or limb ischaemia)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Papworth Hospital
Cambridge, Cambs, CB23 3RE
Stephen Large, FRCS
P Catarino
About this study
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
Read more
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?
- 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?
- Conditions
- Thoracic Aortic Aneurysm
- Being tested
- Stent Grafting (ESR), Open Surgery (OSR)
- Medical subject headings
- Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent Grafting (ESR)Procedure or surgery
Open Surgery (OSR)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Stent Grafting (ESR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm Growth
Measured: 1, 2, 3 , 4 and 5 years post recruitment
Quality of life
Measured: 1, 2, 3 , 4 and 5 years post recruitment
Freedom from reintervention
Measured: 1, 2, 3 , 4 and 5 years post recruitment
Freedom from death or permanent neurological injury
Measured: 1, 2, 3 , 4 and 5 years post recruitment
Costs to the NHS
Measured: 1, 2, 3 , 4 and 5 years post recruitment
Incremental cost per quality adjusted life year gained
Measured: 1, 2, 3 , 4 and 5 years post recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionJan 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Stephen Large, FRCS, Study chair, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010892
- Sponsor's protocol ID
- P01633
- Other IDs
- 11/147/03
- Acronym
- ETTAA
- Status last verified
- May 2016
- First submitted
- 22 Nov 2013
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sharples L, Sastry P, Freeman C, Gray J, McCarthy A, Chiu YD, Bicknell C, McMeekin P, Vallabhaneni SR, Cook A, Vale L, Large S. Endovascular stent grafting and open surgical replacement for chronic thoracic aortic aneurysms: a systematic review and prospective cohort study. Health Technol Assess. 2022 Jan;26(6):1-166. doi: 10.3310/ABUT7744.
PubMed 35094747
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Treatments for Thoracic Aortic Aneurysms (ETTAA Study): A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02010892
- Acronym / sponsor ID
- ETTAA / P01633
- Conditions
- Thoracic Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- Feb 2014
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
- 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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) | – | Procedure: Open Surgery (OSR)Replacement of the aneurysmal aorta with prosthetic conduit via a sternotomy or thoracotomy with circulatory support. |
| Stenting (ESR) | – | Procedure: Stent Grafting (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being referred to a specialist centre for diagnosis and treatment of their aneurysm
Key inclusion criteria (3 listed)
- Thoracic Aortic Aneurysm > 4cm
- Age ≥18 years
- Able to give informed consent
Key exclusion criteria (2 listed)
- Intervention required below the level of the coeliac axis
- Acute dissection or malperfusion syndromes (such as myocardial infarction,acute stroke or limb ischaemia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent Grafting (ESR) | Procedure or surgery | Stenting (ESR) |
| Open Surgery (OSR) | Procedure or surgery | Open Surgery (OSR) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Derived from this study: PubMed 35094747Sharples L, Sastry P, Freeman C, Gray J, McCarthy A, Chiu YD, Bicknell C, McMeekin P, Vallabhaneni SR, Cook A, Vale L, Large S. Endovascular stent grafting and open surgical replacement for chronic thoracic aortic aneurysms: a systematic review and prospective cohort study. Health Technol Assess. 2022 Jan;26(6):1-166. doi: 10.3310/ABUT7744.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Large, FRCS study chair
Papworth Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Aortic Aneurysm, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vikki Hughes, PhD (01480 364821, victoria.hughes@papworth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aneurysm Growth (time frame: 1, 2, 3 , 4 and 5 years post recruitment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02010892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016.