Immediate Management of the Patient With Aneurysm Rupture : Open Versus Endovascular Repair (IMPROVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
University of Cambridge
The Leeds Teaching Hospitals NHS Trust
St George's, University of London
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00746122
First received: September 1, 2008
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

Rupture of the main blood vessel of the body in the abdomen (ruptured abdominal aortic aneurysm) is fatal in over three-quarters of cases. In the past, those that survive have reached hospital alive and undergone emergency open surgery to repair the aneurysm and stop the bleeding: however, after this major emergency surgery only half the patients leave hospital alive. A newer, less-invasive method of aneurysm repair, endovascular repair, is based on repairing the aneurysm by inserting the repair graft up through one of the arteries in the groin. Endovascular repair has been tested in the elective situation and is associated with a 3-fold reduction in operative mortality versus the standard open surgery. Early work with selected patients has suggested that endovascular repair may be associated with up to a 2-fold reduction in operative mortality and more rapid recovery for ruptured abdominal aortic aneurysms. However, only 55-70% patients are anatomically suitable for endovascular repair.

Therefore, this research aims to determine whether a strategy of preferential emergency endovascular repair reduces both the mortality and cost of ruptured abdominal aortic aneurysm.

Critically ill patients with a clinical diagnosis of ruptured aneurysm will be randomised, in the emergency room, to a strategy of endovascular repair if possible (endovascular first) or to current standard care (immediate transfer to the operating theatre for emergency open surgery). Patients randomised to "endovascular first" will require a specialist radiological examination (CT scan) to assess anatomical suitability and plan for endovascular repair. This will cause a short delay before definitive repair can be commenced. Those patients not suitable for endovascular repair, after CT scan, will be taken for standard open surgery. Patients will be randomised at 16-20 specialist centres in the UK, who have already attained sufficient experience in using endovascular repair for ruptured aneurysms and can offer a routine service.

The primary outcome measure is 30-day operative mortality, which we hope will improve by 14% with the "endovascular first" strategy (from 47% to 33%). We also shall measure mortality (in-hospital, one year), costs, quality of life and cost-effectiveness as other key outcomes: all are expected to improve with endovascular repair.

The research team includes specialists in clinical trials, health economics, statistics, pre-hospital & emergency care, interventional radiology, vascular & endovascular surgery, critical care, aneurysm research and a service user.


Condition Intervention
Abdominal Aortic Aneurysm
Procedure: Open repair
Procedure: EVAR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Can Emergency Endovascular Aneurysm Repair (eEVAR) Improve the Survival From Ruptured Abdominal Aortic Aneurism?

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Can a strategy of preferential endovascular repair of ruptured abdominal aortic aneurysm, versus the current practice of open surgical repair, significantly reduce the 30 day mortality of ruptured abdominal aortic aneurysm? [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 613
Study Start Date: September 2009
Estimated Study Completion Date: July 2016
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Immediate Open Surgery
Procedure: Open repair
Immediate open surgery
Experimental: 2
CT and endovascular repair if possible
Procedure: EVAR
Endovascular Aneurysm Repair
Other Name: CT scan

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical suspicion of ruptured abdominal aortic aneurysm after review in Accident and Emergency (or other hospital unit).
  • Men and women over the age of 50 years will be recruited.

Exclusion Criteria:

  • Patients with known connective tissue disorders (eg Marfan syndrome) where endovascular repair may not be beneficial.
  • Patients with known previous repair of an abdominal aortic aneurysm, because procedures either open or endovascular are likely to be very complex and there are no guidelines for anatomical restriction to repair.
  • Deeply unconscious and moribund patients since the chances of recovery are minimal.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746122

Locations
Canada, Ontario
London Health Sciences Centre, University of Western Ontario
London, Ontario, Canada, N6A 5W9
United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom, TR1 3LJ
University Hospital of Wales, Cardiff and Vale NHS Trust
Cardiff, South Glamorgan, United Kingdom, CF14 4 XW
The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Aberdeen Royal Infirmary, NHS Grampian
Aberdeen, United Kingdom, AB25 2ZN
Belfast City Hospital, Belfast Health and Social Care Trust
Belfast, United Kingdom, BT9 7AB
University of Birmingham
Birmingham, United Kingdom, B92 2LJ
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Brighton and Sussex University Hospitals NHS Trust
Brighton, United Kingdom, BN2 5BE
Vascular Unit, Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 2QQ
Kent & Canterbury Hospital
Canterbury, United Kingdom, CT1 3NG
Colchester General Hospital
Colchester, United Kingdom, CO4 5JL
Royal Derby Hospital
Derby, United Kingdom, DE22 3NE
Doncaster and Bassetlaw Hospitals NHS Foundation Trust
Doncaster, United Kingdom, DN10 5HD
NHS Tayside
Dundee, United Kingdom, DD1 9SY
Queen Elizabeth Hospital
Gateshead, United Kingdom, NE96SX
Hull Royal Infirmary
Hull, United Kingdom, HU3 2JZ
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS1 3EX
Leicester Royal Infirmary
Leicester, United Kingdom, LE2 7LX
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 2PR
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1PG
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Royal Free Hampstead NHS Trust
London, United Kingdom, NW3 2QG
St George's Hospital, St George's Healthcare NHS Trust
London, United Kingdom, SW17 0QT
University Hospital of South Manchester
Manchester, United Kingdom, M23 9LT
Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
The James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom, NE7 7DN
Royal Gwent Hospital
Newport, United Kingdom, NP20 2UB
Queen's Medical Centre
Nottingham, United Kingdom, NG7 2UH
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Frimley Park Hospital NHS Foundation Trust
Surrey, United Kingdom, GU16 7UJ
The York Hospital
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Imperial College London
London School of Hygiene and Tropical Medicine
University of Cambridge
The Leeds Teaching Hospitals NHS Trust
St George's, University of London
Investigators
Principal Investigator: Ray J. Ashleigh University Hospital of South Manchester NHS Foundation Trust
Principal Investigator: Simon J. Howell, MA FRCA MRCP(UK) MSc MD Leeds Teaching Hospitals NHS Trust
Principal Investigator: Ian Chetter, MB ChB FRCS Hull & East Yorkshire Hospitals NHS Trust
Principal Investigator: Shane MacSweeney, MA MB BChir MChir FRCSEng Nottingham University Hospitals NHS Trust
Principal Investigator: Matthew J. Bown, MBChB MD FRCS (Gen Surg) University Hospitals, Leicester
Principal Investigator: Jonathan R Boyle, MBChB FRCSEd MD FRCS(Gen) Cambridge Vascular Unit, Addenbrooke's Hospital
Principal Investigator: Meryl Davis, BS, MBBS, FRCS Royal Free Hampstead NHS Trust
Principal Investigator: Matthew Thompson, MD, FRCS St George's Healthcare NHS Trust
Principal Investigator: Nicholas J Cheshire, MB ChB FRCS(Gen) MD Imperial College NHS Trust
Principal Investigator: Dynesh Rittoo, MBChB FRCS The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust
Principal Investigator: Jonathan Davies, MBBS FRCS FRCS(Ed) Royal Cornwall Hospitals NHS Trust
Principal Investigator: Rachel Bell, MS FRCS Guy's & St Thomas' Hospital
Principal Investigator: Mike G Wyatt, MD, FRCS The Newcastle upon Tyne Hospitals NHS Trust
Principal Investigator: Ferdinand Serracino-Inglott, MD, MSc, FRCSI, FRCS Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
Principal Investigator: Paul Bachoo, MBChB FRCS MSc Aberdeen Royal Infirmary
Principal Investigator: Woolagasen Pillay, MBBch BSc FCS(SA) Doncaster Royal Infirmary
Principal Investigator: Syed Yusuf, MD MBBS DM FRCS Royal Sussex County Hospital
Principal Investigator: Paul Walker The James Cook University Hospital , South Tees Hospitals NHS Foundation Trust
Principal Investigator: Colin Nice Queen Elizabeth Hospital, Gateshead Health NHS Foundation Trust
Principal Investigator: Andrew Gordon, MBBS MRCP FRCS Cardiff and Vale University Health Board
Principal Investigator: Adam Howard, MBBS BMedSci FRCS Colchester General Hospital
Principal Investigator: Noel Wilson, MBBS FRCS MS Kent and Canterbury Hospital
Principal Investigator: Domenico Valenti, MD PhD FRCS FEBVS King's College Hospital NHS Trust
Principal Investigator: David McLain, MBBS, FRCS (Gen Surg), FEBVS Aneurin Bevan Health Board
Principal Investigator: Patrick Chong, MB BS FRCS Frimley Park Hospital NHS Foundation Trust
Principal Investigator: Raj Bhat, MS,FRCS(Ed),FRCR NHS Tayside
Principal Investigator: Thomas Forbes, MD, FRCSC, FACS London Health Sciences Centre, University of Western Ontario, Canada
Principal Investigator: Simon Hobbs, MBChB, MD, FRCS (Eng), BMedSc The Royal Wolverhampton Hospitals NHS Trust
Principal Investigator: Stephen Cavanagh, MBChB, MD, FRCS(Gen) York Teaching Hospital NHS Foundation Trust
Principal Investigator: Timothy Rowlands, MB ChB, FRCS (Eng) Derby Hospitals NHS Foundation Trust
Principal Investigator: John Asquith, MB ChB, MRCP, FRCR University Hospital of North Staffordshire
  More Information

Additional Information:
No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00746122     History of Changes
Other Study ID Numbers: HTA07/37/64
Study First Received: September 1, 2008
Last Updated: February 12, 2014
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014