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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00746122
First Posted: September 3, 2008
Last Update Posted: September 4, 2017
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.
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
September 1, 2008
September 3, 2008
September 4, 2017
September 2009
August 21, 2013   (Final data collection date for primary outcome measure)
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, 1-year and 3-years from randomisation ]
mortality
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 ]
Complete list of historical versions of study NCT00746122 on ClinicalTrials.gov Archive Site
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: 1-year and 3-years from randomisation ]
Re-interventions, costs, quality of life, QALYs and cost-effectiveness associated with the two treatment strategies
Not Provided
Not Provided
Not Provided
 
Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair
Can Emergency Endovascular Aneurysm Repair (eEVAR) Improve the Survival From Ruptured Abdominal Aortic Aneurysm?
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.

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%). 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Abdominal Aortic Aneurysm
  • Procedure: Open repair
    Standard treatment of emergency open surgery
    Other Names:
    • open surgical repair
    • open surgery
  • Procedure: EVAR
    Emergency endovascular aneurysm repair
    Other Name: Endovascular Aneurysm Repair
  • Open repair
    Immediate Open Surgery
    Intervention: Procedure: Open repair
  • Experimental: Endovascular strategy
    Endovascular strategy involves immediate computed tomography (CT) and emergency EVAR, with open repair for patients anatomically unsuitable for EVAR
    Intervention: Procedure: EVAR

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
613
July 21, 2016
August 21, 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United Kingdom
 
 
NCT00746122
HTA07/37/64
ISRCTN48334791 ( Registry Identifier: ISRCTN registry )
Yes
Not Provided
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 mjs212@medschl.cam.ac.uk after approval by the Trial Management Committee.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Analytic Code
Time Frame: The data will become available in December 2017 and for the subsequent 3 years.
Imperial College London
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
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: Colin D Bicknell, BM MD FRCS 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 W 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: Luc Dubois, MD, MSc 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
Imperial College London
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP