Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair
IMPROVE
Can Emergency Endovascular Aneurysm Repair (eEVAR) Improve the Survival From Ruptured Abdominal Aortic Aneurysm?
2 other identifiers
interventional
613
2 countries
30
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2009
Longer than P75 for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2008
CompletedFirst Posted
Study publicly available on registry
September 3, 2008
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2016
CompletedResults Posted
Study results publicly available
December 19, 2019
CompletedDecember 19, 2019
December 1, 2019
4 years
September 1, 2008
March 20, 2019
December 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
Mortality, at 3 pre-specified time points
30 days, 1-year and 3-years from randomisation
Secondary Outcomes (2)
Quality-adjusted Life Years (QALYs) to Enable Cost-effectiveness Evaluation
3-years from randomisation
Hospital Costs to Enable Cost-effectiveness Evaluation
3 years
Study Arms (2)
Open repair
OTHERImmediate Open Surgery
Endovascular strategy
EXPERIMENTALEndovascular strategy involves immediate computed tomography (CT) and emergency Endovascular aneurysm repair (EVAR), with open repair for patients anatomically unsuitable for EVAR
Interventions
Standard treatment of emergency open surgery
Emergency endovascular aneurysm repair
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- London School of Hygiene and Tropical Medicinecollaborator
- University of Cambridgecollaborator
- The Leeds Teaching Hospitals NHS Trustcollaborator
- St George's, University of Londoncollaborator
Study Sites (30)
London Health Sciences Centre, University of Western Ontario
London, Ontario, N6A 5W9, Canada
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ, United Kingdom
University Hospital of Wales, Cardiff and Vale NHS Trust
Cardiff, South Glamorgan, CF14 4 XW, United Kingdom
The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
Aberdeen Royal Infirmary, NHS Grampian
Aberdeen, AB25 2ZN, United Kingdom
Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 5BE, United Kingdom
Vascular Unit, Addenbrooke's Hospital
Cambridge, CB2 2QQ, United Kingdom
Kent & Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
Colchester General Hospital
Colchester, CO4 5JL, United Kingdom
Royal Derby Hospital
Derby, DE22 3NE, United Kingdom
Doncaster and Bassetlaw Hospitals NHS Foundation Trust
Doncaster, DN10 5HD, United Kingdom
NHS Tayside
Dundee, DD1 9SY, United Kingdom
Frimley Park Hospital NHS Foundation Trust
Frimley, GU16 7UJ, United Kingdom
Queen Elizabeth Hospital
Gateshead, NE96SX, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX, United Kingdom
Leicester Royal Infirmary
Leicester, LE2 7LX, United Kingdom
Royal Free Hampstead NHS Trust
London, NW3 2QG, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, SE1 2PR, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
St George's Hospital, St George's Healthcare NHS Trust
London, SW17 0QT, United Kingdom
Imperial College Healthcare NHS Trust
London, W2 1PG, United Kingdom
Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
University Hospital of South Manchester
Manchester, M23 9LT, United Kingdom
The James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE7 7DN, United Kingdom
Royal Gwent Hospital
Newport, NP20 2UB, United Kingdom
Queen's Medical Centre
Nottingham, NG7 2UH, United Kingdom
The York Hospital
York, YO31 8HE, United Kingdom
Related Publications (5)
IMPROVE Trial Investigators; Powell JT, Sweeting MJ, Thompson MM, Ashleigh R, Bell R, Gomes M, Greenhalgh RM, Grieve R, Heatley F, Hinchliffe RJ, Thompson SG, Ulug P. Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial. BMJ. 2014 Jan 13;348:f7661. doi: 10.1136/bmj.f7661.
PMID: 24418950RESULTIMPROVE Trial Investigators. Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: one-year outcomes from the IMPROVE randomized trial. Eur Heart J. 2015 Aug 14;36(31):2061-2069. doi: 10.1093/eurheartj/ehv125. Epub 2015 Apr 7.
PMID: 25855369RESULTSweeting MJ, Balm R, Desgranges P, Ulug P, Powell JT; Ruptured Aneurysm Trialists. Individual-patient meta-analysis of three randomized trials comparing endovascular versus open repair for ruptured abdominal aortic aneurysm. Br J Surg. 2015 Sep;102(10):1229-39. doi: 10.1002/bjs.9852. Epub 2015 Jun 24.
PMID: 26104471RESULTIMPROVE Trial Investigators. Comparative clinical effectiveness and cost effectiveness of endovascular strategy v open repair for ruptured abdominal aortic aneurysm: three year results of the IMPROVE randomised trial. BMJ. 2017 Nov 14;359:j4859. doi: 10.1136/bmj.j4859.
PMID: 29138135RESULTUlug P, Hinchliffe RJ, Sweeting MJ, Gomes M, Thompson MT, Thompson SG, Grieve RJ, Ashleigh R, Greenhalgh RM, Powell JT. Strategy of endovascular versus open repair for patients with clinical diagnosis of ruptured abdominal aortic aneurysm: the IMPROVE RCT. Health Technol Assess. 2018 May;22(31):1-122. doi: 10.3310/hta22310.
PMID: 29860967DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor Janet Powell
- Organization
- Imperial College London
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2008
First Posted
September 3, 2008
Study Start
September 1, 2009
Primary Completion
August 21, 2013
Study Completion
July 21, 2016
Last Updated
December 19, 2019
Results First Posted
December 19, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- The data will become available in December 2017 and for the subsequent 3 years.
The datasets generated during and/or analysed during the current study are/will be available upon request from mjs212@medschl.cam.ac.uk after approval by the Trial Management Committee.