Abdominal Aortic AneurysmIMPROVENCT00746122
Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair
A study testing Open repair and EVAR in people with Abdominal Aortic Aneurysm, run by Imperial College London at 30 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Open repair and EVAR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 613 participants
- Where
- 30 sitesin 2 countries
- Study dates
- Sep 2009to 21 Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United Kingdom29 sites
Aberdeen Royal Infirmary, NHS Grampian
Aberdeen, AB25 2ZN
Royal Bournemouth Hospital
Bournemouth, BH7 7DW
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 5BE
Vascular Unit, Addenbrooke's Hospital
Cambridge, CB2 2QQ
Kent & Canterbury Hospital
Canterbury, CT1 3NG
University Hospital of Wales, Cardiff and Vale NHS Trust
Cardiff, South Glamorgan, CF14 4 XW
Colchester General Hospital
Colchester, CO4 5JL
Royal Derby Hospital
Derby, DE22 3NE
Doncaster and Bassetlaw Hospitals NHS Foundation Trust
Doncaster, DN10 5HD
NHS Tayside
Dundee, DD1 9SY
Frimley Park Hospital NHS Foundation Trust
Frimley, GU16 7UJ
Queen Elizabeth Hospital
Gateshead, NE96SX
Hull Royal Infirmary
Hull, HU3 2JZ
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3EX
Leicester Royal Infirmary
Leicester, LE2 7LX
Royal Free Hampstead NHS Trust
London, NW3 2QG
Guy's and St Thomas' NHS Foundation Trust
London, SE1 2PR
King's College Hospital NHS Foundation Trust
London, SE5 9RS
St George's Hospital, St George's Healthcare NHS Trust
London, SW17 0QT
Imperial College Healthcare NHS Trust
London, W2 1PG
Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL
University Hospital of South Manchester
Manchester, M23 9LT
The James Cook University Hospital
Middlesbrough, TS4 3BW
Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE7 7DN
Royal Gwent Hospital
Newport, NP20 2UB
Queen's Medical Centre
Nottingham, NG7 2UH
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ
The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, West Midlands, WV10 0QP
The York Hospital
York, YO31 8HE
Canada1 site
London Health Sciences Centre, University of Western Ontario
London, Ontario, N6A 5W9
About this study
Official title: 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 (AAA).
Read the 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.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Open repair, EVAR
- Keywords
- Abdominal Aortic Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open repairProcedure or surgery
Also called open surgical repair, open surgery
Standard treatment of emergency open surgery
EVARProcedure or surgery
Also called Endovascular Aneurysm Repair (EVAR)
Emergency endovascular aneurysm repair
| Study group | Role | What they receive |
|---|---|---|
| Open repair | Other | Immediate Open Surgery Receives: Procedure: Open repair |
| Endovascular strategy | Experimental | Endovascular strategy involves immediate computed tomography (CT) and emergency Endovascular aneurysm repair (EVAR), with open repair for patients anatomically unsuitable for EVAR Receives: Procedure: EVAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality, at 3 pre-specified time points
Measured: 30 days, 1-year and 3-years from randomisation
Secondary outcomes (2)
Quality-adjusted Life Years (QALYs) to Enable Cost-effectiveness Evaluation
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.
Measured: 3-years from randomisation
Hospital Costs to Enable Cost-effectiveness Evaluation
Hospital costs to enable cost-effectiveness evaluation in Pounds (£)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startSep 2009
- Primary completion21 Aug 2013
- Study completion21 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University of Cambridge, The Leeds Teaching Hospitals NHS Trust, St George's, University of London
- Responsible party
- Sponsor
- Investigators
- Ray J. Ashleigh, Principal investigator, Manchester University NHS Foundation TrustSimon J. Howell, MRCP(UK) MSc MD, Principal investigator, Leeds Teaching Hospitals NHS TrustIan Chetter, FRCS, Principal investigator, Hull & East Yorkshire Hospitals NHS TrustShane MacSweeney, MA MB BChir MChir FRCSEng, Principal investigator, Nottingham University Hospitals NHS TrustMatthew J. Bown, MBChB MD FRCS (Gen Surg), Principal investigator, University Hospitals, LeicesterJonathan R Boyle, FRCSEd MD FRCS(Gen), Principal investigator, Cambridge Vascular Unit, Addenbrooke's HospitalMeryl Davis, FRCS, Principal investigator, Royal Free Hampstead NHS TrustMatthew Thompson, FRCS, Principal investigator, St George's Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746122
- Sponsor's protocol ID
- HTA07/37/64
- Other IDs
- ISRCTN48334791
- Acronym
- IMPROVE
- Status last verified
- Dec 2019
- First submitted
- 1 Sep 2008
- Last updated
- 19 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 24418950IMPROVE 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.
PubMed 25855369Sweeting 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.
PubMed 26104471IMPROVE 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.
PubMed 29138135Ulug 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.
PubMed 29860967
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Emergency Endovascular Aneurysm Repair (eEVAR) Improve the Survival From Ruptured Abdominal Aortic Aneurysm?
- ClinicalTrials.gov ID
- NCT00746122
- Acronym / sponsor ID
- IMPROVE / HTA07/37/64
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, University of Cambridge, The Leeds Teaching Hospitals NHS Trust, St George's, University of London
- Study start
- Sep 2009 (actual)
- Primary completion
- 21 Aug 2013 (actual)
- Study completion
- 21 Jul 2016 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Posted 19 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open repair | Other | Procedure: Open repairImmediate Open Surgery |
| Endovascular strategy | Experimental | Procedure: EVAREndovascular strategy involves immediate computed tomography (CT) and emergency Endovascular aneurysm repair (EVAR), with open repair for patients anatomically unsuitable for EVAR |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open repairAlso: open surgical repair, open surgeryStandard treatment of emergency open surgery | Procedure or surgery | Open repair |
| EVARAlso: Endovascular Aneurysm Repair (EVAR)Emergency endovascular aneurysm repair | Procedure or surgery | Endovascular strategy |
Primary outcome
Mortality
Time frame: 30 days, 1-year and 3-years from randomisation
Mortality, at 3 pre-specified time points
2 secondary outcomes
Quality-adjusted Life Years (QALYs) to Enable Cost-effectiveness Evaluation
Time frame: 3-years from randomisation
Hospital Costs to Enable Cost-effectiveness Evaluation
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24418950IMPROVE 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.
- Results publication: PubMed 25855369IMPROVE 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.
- Results publication: PubMed 26104471Sweeting 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.
- Results publication: PubMed 29138135IMPROVE 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.
- Derived from this study: PubMed 29860967Ulug 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.
- Improve trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ray J. Ashleigh principal investigator
Manchester University NHS Foundation Trust
Simon J. Howell, MRCP(UK) MSc MD principal investigator
Leeds Teaching Hospitals NHS Trust
Ian Chetter, FRCS principal investigator
Hull & East Yorkshire Hospitals NHS Trust
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open repair and EVAR in people with Abdominal Aortic Aneurysm, run by Imperial College London at 30 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days, 1-year and 3-years from randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00746122, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.