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

Abdominal Aortic Aneurysm Clinical Trial

— IMPROVE  

Official title:

Can Emergency Endovascular Aneurysm Repair (eEVAR) Improve the Survival From Ruptured Abdominal Aortic Aneurysm?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746122
• Other study ID #: HTA07/37/64
• Secondary ID: ISRCTN48334791
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: July 21, 2016

Study information

• Verified date: December 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 613
• Est. completion date: July 21, 2016
• Est. primary completion date: August 21, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Procedure:
• Open repair
Standard treatment of emergency open surgery
• EVAR
Emergency endovascular aneurysm repair

Locations

Country	Name	City	State
Canada	London Health Sciences Centre, University of Western Ontario	London	Ontario
United Kingdom	Aberdeen Royal Infirmary, NHS Grampian	Aberdeen
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Brighton and Sussex University Hospitals NHS Trust	Brighton
United Kingdom	Vascular Unit, Addenbrooke's Hospital	Cambridge
United Kingdom	Kent & Canterbury Hospital	Canterbury
United Kingdom	University Hospital of Wales, Cardiff and Vale NHS Trust	Cardiff	South Glamorgan
United Kingdom	Colchester General Hospital	Colchester
United Kingdom	Royal Derby Hospital	Derby
United Kingdom	Doncaster and Bassetlaw Hospitals NHS Foundation Trust	Doncaster
United Kingdom	NHS Tayside	Dundee
United Kingdom	Frimley Park Hospital NHS Foundation Trust	Frimley
United Kingdom	Queen Elizabeth Hospital	Gateshead
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Leicester Royal Infirmary	Leicester
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	Royal Free Hampstead NHS Trust	London
United Kingdom	St George's Hospital, St George's Healthcare NHS Trust	London
United Kingdom	Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust	Manchester
United Kingdom	University Hospital of South Manchester	Manchester
United Kingdom	The James Cook University Hospital	Middlesbrough
United Kingdom	Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle
United Kingdom	Royal Gwent Hospital	Newport
United Kingdom	Queen's Medical Centre	Nottingham
United Kingdom	Royal Cornwall Hospital	Truro	Cornwall
United Kingdom	The Royal Wolverhampton Hospitals NHS Trust	Wolverhampton	West Midlands
United Kingdom	The York Hospital	York

Sponsors (5)

Lead Sponsor	Collaborator
Imperial College London	London School of Hygiene and Tropical Medicine, St George's, University of London, The Leeds Teaching Hospitals NHS Trust, University of Cambridge

Countries where clinical trial is conducted

Canada,  United Kingdom, 

References & Publications (4)

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 outc — View Citation

IMPROVE 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: 10.1 — View Citation

IMPROVE 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. Epub 2015 Apr 7. — View Citation

Sweeting 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):12 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality, at 3 pre-specified time points	30 days, 1-year and 3-years from randomisation
Secondary	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.	3-years from randomisation
Secondary	Hospital Costs to Enable Cost-effectiveness Evaluation	Hospital costs to enable cost-effectiveness evaluation in Pounds (£)	3 years

External Links

•   Improve trial website