Ignite Creation Date:
2024-05-05 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00746122
Status:
COMPLETED
Last Update Posted:
2019-12-19
First Post:
2008-09-01
Brief Title:
Immediate Management of the Patient With Rupture Open Versus Endovascular Repair
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Can Emergency Endovascular Aneurysm Repair eEVAR Improve the Survival From Ruptured Abdominal Aortic Aneurysm
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPROVE
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN48334791 | REGISTRY | ISRCTN registry | None |