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

NCT02010892 | Unknown DMC

• 2 other identifiers: P0163311/147/03
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.How does QoL change from pre- to post intervention?
4. 4.Can aneurysm or patient related predictors of good/poor treatment outcomes be determined?
5. 5.What is the most cost-effective strategy in:
6. 6.Patients eligible for either ESG or OSR?
7. 7.Patients eligible for either ESG or best medical therapy (BMT)?
8. 8.Patients eligible for either watchful waiting (WW) or intervention (ESG/ OSR)?
9. 9.What further research is required? What would be the most important research to pursue?

Conditions

Thoracic Aortic Aneurysm

Outcome Measures

Primary Outcomes (6)

• Aneurysm Growth

  1, 2, 3 , 4 and 5 years post recruitment

• Quality of life

  1, 2, 3 , 4 and 5 years post recruitment

• Freedom from reintervention

  1, 2, 3 , 4 and 5 years post recruitment

• Freedom from death or permanent neurological injury

  1, 2, 3 , 4 and 5 years post recruitment

• Costs to the NHS

  1, 2, 3 , 4 and 5 years post recruitment

• Incremental cost per quality adjusted life year gained

  1, 2, 3 , 4 and 5 years post recruitment

Study Arms (4)

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)

Interventions

Stent Grafting (ESR) PROCEDURE

Stenting (ESR)

Open Surgery (OSR) PROCEDURE

Open Surgery (OSR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Thoracic Aortic Aneurysm \> 4cm
• Age ≥18 years
• Able to give informed consent

You may not qualify if:

• Intervention required below the level of the coeliac axis
• Acute dissection or malperfusion syndromes (such as myocardial infarction,acute stroke or limb ischaemia)

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (1)

Papworth Hospital

Cambridge, Cambs, CB23 3RE, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 35094747 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Interventions

Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Stephen Large, FRCS

  Papworth Hospital NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Vikki Hughes, PhD

CONTACT

01480 364821; victoria.hughes@papworth.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: December 13, 2013
• Study Start: February 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2019
• Last Updated: May 6, 2016

Record last verified: 2016-05

Locations

GB (1)