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

NCT02010892 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2200

Last updated 2016-05-06

No results posted yet for this study

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?

Conditions

  • Thoracic Aortic Aneurysm

Interventions

PROCEDURE

Stent Grafting (ESR)

PROCEDURE

Open Surgery (OSR)

Sponsors & Collaborators

  • Papworth Hospital NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Stephen Large, FRCS · Papworth Hospital NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2019-01-31
Completion
2019-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02010892 on ClinicalTrials.gov