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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00746122
Recruitment Status : Completed
First Posted : September 3, 2008
Results First Posted : December 19, 2019
Last Update Posted : December 19, 2019
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

Brief Summary:
The purpose of this trial is to assess whether a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair reduces early mortality for patients with suspected ruptured abdominal aortic aneurysm (AAA).

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Procedure: Open repair Procedure: EVAR Not Applicable

Detailed Description:

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 (computed tomography, 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 United Kingdom (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%). Secondary outcome measures include 24h, in-hospital and 1-year and 3-year mortality, re-interventions associated with the two treatment strategies as well as quality of life, costs and cost-effectiveness.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 613 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Can Emergency Endovascular Aneurysm Repair (eEVAR) Improve the Survival From Ruptured Abdominal Aortic Aneurysm?
Actual Study Start Date : September 2009
Actual Primary Completion Date : August 21, 2013
Actual Study Completion Date : July 21, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Open repair
Immediate Open Surgery
Procedure: Open repair
Standard treatment of emergency open surgery
Other Names:
  • open surgical repair
  • open surgery

Experimental: Endovascular strategy
Endovascular strategy involves immediate computed tomography (CT) and emergency Endovascular aneurysm repair (EVAR), with open repair for patients anatomically unsuitable for EVAR
Procedure: EVAR
Emergency endovascular aneurysm repair
Other Name: Endovascular Aneurysm Repair (EVAR)

Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days, 1-year and 3-years from randomisation ]
    Mortality, at 3 pre-specified time points

Secondary Outcome Measures :
  1. Quality-adjusted Life Years (QALYs) to Enable Cost-effectiveness Evaluation [ Time Frame: 3-years from randomisation ]

    QALYs are a product of length of life and quality of life, since both of these are important to patients. Therefore, it is a measure of the state of health of a person or group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health.

    QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale). It is often measured in terms of the person's ability to carry out the activities of daily life, and freedom from pain and mental disturbance.

  2. Hospital Costs to Enable Cost-effectiveness Evaluation [ Time Frame: 3 years ]
    Hospital costs to enable cost-effectiveness evaluation in Pounds (£)

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00746122

Show Show 30 study locations
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
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Principal Investigator: Ray J. Ashleigh Manchester University NHS Foundation Trust
Principal Investigator: Simon J. Howell, MRCP(UK) MSc MD Leeds Teaching Hospitals NHS Trust
Principal Investigator: Ian Chetter, 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, FRCSEd MD FRCS(Gen) Cambridge Vascular Unit, Addenbrooke's Hospital
Principal Investigator: Meryl Davis, FRCS Royal Free Hampstead NHS Trust
Principal Investigator: Matthew Thompson, FRCS St George's Healthcare NHS Trust
Principal Investigator: Colin D Bicknell, FRCS Imperial College NHS Trust
Principal Investigator: Dynesh Rittoo, MBChB FRCS The Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust
Principal Investigator: Jonathan Davies, FRCS FRCS(Ed) Royal Cornwall Hospitals NHS Trust
Principal Investigator: Rachel Bell, FRCS Guy's & St Thomas' Hospital
Principal Investigator: Mike G Wyatt, FRCS The Newcastle upon Tyne Hospitals NHS Trust
Principal Investigator: Ferdinand Serracino-Inglott, 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, FCS(SA) Doncaster Royal Infirmary
Principal Investigator: Syed W Yusuf, 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, FRCS Cardiff and Vale University Health Board
Principal Investigator: Adam Howard, FRCS Colchester General Hospital
Principal Investigator: Noel Wilson, FRCS MS Kent and Canterbury Hospital
Principal Investigator: Domenico Valenti, 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, FRCS Frimley Park Hospital NHS Foundation Trust
Principal Investigator: Raj Bhat,,FRCS(Ed),FRCR NHS Tayside
Principal Investigator: Luc Dubois, MSc London Health Sciences Centre, University of Western Ontario, Canada
Principal Investigator: Simon Hobbs, 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, FRCS (Eng) University Hospitals of Derby and Burton NHS Foundation Trust
Principal Investigator: John Asquith, MRCP, FRCR University Hospital of North Staffordshire
Additional Information:
Study Data/Documents: Study Protocol  This link exits the site
Final protocol version 6.0 dated 28th August 2013

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Imperial College London Identifier: NCT00746122    
Other Study ID Numbers: HTA07/37/64
ISRCTN48334791 ( Registry Identifier: ISRCTN registry )
First Posted: September 3, 2008    Key Record Dates
Results First Posted: December 19, 2019
Last Update Posted: December 19, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The datasets generated during and/or analysed during the current study are/will be available upon request from after approval by the Trial Management Committee.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: The data will become available in December 2017 and for the subsequent 3 years.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Abdominal Aortic Aneurysm
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases