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| [ Print-friendly version ] |
| EndoVascular Aneurysm Repair (EVAR) Trials 1 and 2 |
| ISRCTN | ISRCTN55703451 |
| ClinicalTrials.gov identifier | |
| Public title | EndoVascular Aneurysm Repair (EVAR) Trials 1 and 2 |
| Scientific title | EndoVascular Aneurysm Repair (EVAR) randomised controlled trial in patients with abdominal aortic aneurysm (EVAR 1 and 2) |
| Acronym | EVAR |
| Serial number at source | HTA 95/02/99; HTA 95/02/02 |
| Study hypothesis |
Endovascular Aneurysm Repair (EVAR) to exclude Abdominal Aortic Aneurysm (AAA) was introduced in the early 1990’s for patients of poor health status considered unfit for major surgery. As the technology has progressed, EVAR has become an alternative choice of treatment for patients considered fit for open repair as it is minimally invasive and generally involves a shorter stay in hospital. The two EndoVascular Aneurysm Repair (EVAR) Trials were instigated to assess the safety and efficacy of endovascular aneurysm repair in the treatment of AAA in terms of mortality, quality of life, durability and cost-effectiveness for patients considered fit (EVAR Trial 1) or unfit (EVAR Trial 2) for open repair.
Please note that the scientific title has been added as of 03/02/2009. |
| Lay summary | Not provided at time of registration |
| Ethics approval |
MREC North West, approved on 28/04/1998:
EVAR Trial 1, ref: 98/8/26 EVAR Trial 2, ref: 98/8/27 |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Cardiovascular diseases: peripheral arterial disease |
| Participants - 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 |
| Participants - exclusion criteria |
EVAR Trial 1:
Does not match inclusion criteria EVAR Trial 2: Patients with hostile abdomen anatomically unsuitable for open repair but anaesthetically well enough for the open operation were excluded. |
| Anticipated start date | 01/07/1999 |
| Anticipated end date | 30/06/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | EVAR 1: 900; EVAR 2: 280 (total 1180) |
| Interventions |
EVAR Trial 1:
EVAR versus open repair in patients considered fit for open repair. EVAR Trial 2: EVAR and medical management versus medical management alone in patients considered unfit for open repair Randomisation closed at the end of June 2005 by which time 1656 patients had been enrolled (1082 into EVAR Trial 1 and 404 into EVAR Trial 2). Follow-up continues until the end of 2009. |
| Primary outcome measure(s) |
All-cause and aneurysm-related mortality.
Added as of 06/02/2009: Follow-up will be until the end of 2009. |
| Secondary outcome measure(s) |
1. Health Related Quality of Life (HRQL):
1.1. SF-36® Health Survey at 1 year 1.2. Euroqol EQ-5D, assessed annually until the end of 2009 1.3. Patient Generated Index at 1 year 1.4. Stait-Trait Anxiety Index at 1 year 2. Durability of AAA grafts and incidence of complications and re-interventions, followed-up until the end of 2009 3. Costs and cost effectiveness. Data will be collected until the end of 2009. 4. Renal function, assessed annually until the end of 2009 Please note that methods of assessment for HRQL and the timepoints of assessment for all secondary outcome measures were added as of 06/02/2009. |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | http://www.evartrials.org/ |
| Publications |
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. 2012 results on EVAR versus standard therapy in http://www.ncbi.nlm.nih.gov/pubmed/22381040 |
| Contact name | Prof Roger Greenhalgh |
| Address |
Department of Surgery
Charing Cross Hospital |
| City/town | London |
| Zip/Postcode | W6 8RF |
| Country | United Kingdom |
| Tel | +44 (0)20 8846 7316 |
| Fax | +44 (0)20 8846 7330 |
| r.greenhalgh@imperial.ac.uk | |
| Sponsor | Imperial College London (UK) |
| Address | South Kensington Campus |
| City/town | London |
| Zip/Postcode | SW7 2AZ |
| Country | United Kingdom |
| Sponsor website: | http://www3.imperial.ac.uk/ |
| Date applied | 25/04/2003 |
| Last edited | 05/04/2012 |
| Date ISRCTN assigned | 25/04/2003 |
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| © 2012 ISRCTN unless otherwise stated. | |
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