Endovascular aneurysm repair (EVAR) trials 1 and 2

Completed

• Conditions: Cardiovascular diseases: peripheral arterial disease; Circulatory System; Peripheral arterial disease

• Registration Number: ISRCTN55703451
• Lead Sponsor: Imperial College London (UK)

Brief Summary

1. 2004 publication on trial design, methodology and progress in http://www.ncbi.nlm.nih.gov/pubmed/15015186 2. 2004 results on 30-day operative mortality in http://www.ncbi.nlm.nih.gov/pubmed/15351191 3. 2005 results of EVAR trial 1 in http://www.ncbi.nlm.nih.gov/pubmed/15978925 4. 2005 results of EVAR trial 2 in http://www.ncbi.nlm.nih.gov/pubmed/15978926 5. 2007 results on patient fitness and survival in http://www.ncbi.nlm.nih.gov/pubmed/17514695 6. 2007 device-specific results of secondary interventions and mortality in http://www.ncbi.nlm.nih.gov/pubmed/17572116 7. 2008 results on long-term cost-effectiveness in http://www.ncbi.nlm.nih.gov/pubmed/17876749 8. 2008 results on the rupture rate of large abdominal aortic aneurysms in http://www.ncbi.nlm.nih.gov/pubmed/18156938 9. 2010 results on rate of cardiovascular events in EVAR trial 2 in http://www.ncbi.nlm.nih.gov/pubmed/20096611 10. 2010 results on endovascular repair in patients physically ineligible for open repair in http://www.ncbi.nlm.nih.gov/pubmed/20382982 11. 2010 results on endovascular versus open repair in http://www.ncbi.nlm.nih.gov/pubmed/20382983 12. 2010 results on the rate and predictability of graft rupture in http://www.ncbi.nlm.nih.gov/pubmed/21037436 (added 02/06/2016) 13. 2012 results on EVAR versus standard therapy in http://www.ncbi.nlm.nih.gov/pubmed/22381040 14. 2016 15-years' follow-up results in: https://www.ncbi.nlm.nih.gov/pubmed/27743617 15. 2018 long-term follow-up results in https://www.ncbi.nlm.nih.gov/pubmed/29384470

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-04-25
• Study Completion: 2016-08-31
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2645

Inclusion Criteria

EVAR Trial 1:
1. Males or females
2. Aged at least 60 years
3. Abdominal Aortic Aneurysm (AAA) measuring at least 5.5 cm on a Computed Tomography (CT) scan
4. AAA deemed anatomically suitable for an EndoVascular Aneurysm Repair (EVAR) device
5. Patient considered anaesthetically fit for an open repair

EVAR Trial 2:
1. Males or females
2. Aged at least 60 years
3. Abdominal Aortic Aneurysm (AAA) measuring at least 5.5 cm on a CT scan
4. AAA deemed anatomically suitable for an EndoVascular Aneurysm Repair (EVAR) device
5. Patient considered anaesthetically unfit for an open repair

Exclusion Criteria

EVAR Trial 1:
1. Does not match inclusion criteria
2. Not fit for open repair (added 27/05/2016)

EVAR Trial 2:
Patients with hostile abdomen anatomically unsuitable for open repair but anaesthetically well enough for the open operation were excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause and aneurysm-related mortality. <br><br>Added 27/05/2016:<br>Follow-up will be until the end of June 2015<br><br>Previous:<br>Follow-up will be until the end of 2009