Ignite Creation Date:
2024-05-05 @ 11:05 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01253252
Status:
COMPLETED
Last Update Posted:
2017-07-28
First Post:
2010-02-05
Brief Title:
Endoprosthesis Treatment Effects on Human Abdominal Aorta Aneurysms AAA Metabolic Activity
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Endoprosthesis Treatment Effects on Human Abdominal Aorta AneurysmsAAAMetabolic Activity
Status:
COMPLETED
Status Verified Date:
2017-07
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:
AAAendo
Brief Summary:
The purpose of this study is to determine whether Positron Emission Tomography imaging can help to predict the evolutivity of AAA treated with endovascular prosthesis
Detailed Description:
Background
Abdominal Aorta AneurysmAAA is a frequently occurring atherothrombotic disease linked to male gender and aging Due to the current aging of the population the incidence of rupture may be increasing The clinical evaluation of AAA usually includes a morphological assessmentsize and localization for diagnosis open surgery or endovascular prosthesis EVAR may be indicated to prevent the onset of a rupture which is often lethal Unfortunately the durability of endovascular repair of AAA remains uncertain and the rupture risk or endoleaks onset requires continuous surveillance and the conventional imaging by CT scan often fails to predict this negative progression
Our hypothesis is that the therapeutic efficacity of endovascular surgery in the AAA is linked to the restoration of effective compartmentalization between the blood and the outer wall removal of the thrombosis interface and blood pressure constraint Thus success of EVAR must be followed by the disappearance of adventitial inflammation visualized by metabolic activity in FDG-PET 18FDG uptake and a normalization of biological markers of the injury Conversely the inefficacy of endovascular therapy should result in the persistence of an inflammatory metabolic activity in relation to the saccular endoleak and a persistent elevation of plasma biomarkers
Primary objective
The general aim of this pilot study is to assess the effect of endoprosthesis treatment on PET scan functional imaging of AAA
Materials and method
Seven French Hospitals will recruit 50 patients presenting a large AAA scheduled for EVAR Endovascular prosthesis within one month A 18FDG PET scan will be added to their conventional follow up CT scan usual blood sampling ECG ie within one month before endovascular surgery inclusion visit at one month and 6 month of follow-up
Furthermore biological markers of the inflammation proteolysis and coagulation potentially related to morphology and evolution of AAA will be investigated by the U698 National Institute for Medical Research Unit implementing already existing database from others cohorts of patients with AAA including biological samples conserved both by the Nancy clinical investigation center and the U698 National Institute for Medical Research Unit
Study duration for a patient 26 months
Perspectives
This pilot study will help to assess the effect of EVAR in terms of it functional inflammatory response and determine the required sample size for a future project Since aneurysm expansion rate varies widely among patients and even for one single patient over time studying metabolic adventitial immuno-inflammatory activity using 18FDG PET imaging will provide new major informations about the efficacity of endovascular therapy in AAA Plasma assays will help to identify intermediate biological markers of aneurysm evolutivity after endovascular therapy Those complementary functional and biological criteria are of paramount importance to improve therapeutic management and prognosis of AAA
Abdominal Aorta AneurysmAAA is a frequently occurring atherothrombotic disease linked to male gender and aging Due to the current aging of the population the incidence of rupture may be increasing The clinical evaluation of AAA usually includes a morphological assessmentsize and localization for diagnosis open surgery or endovascular prosthesis EVAR may be indicated to prevent the onset of a rupture which is often lethal Unfortunately the durability of endovascular repair of AAA remains uncertain and the rupture risk or endoleaks onset requires continuous surveillance and the conventional imaging by CT scan often fails to predict this negative progression
Our hypothesis is that the therapeutic efficacity of endovascular surgery in the AAA is linked to the restoration of effective compartmentalization between the blood and the outer wall removal of the thrombosis interface and blood pressure constraint Thus success of EVAR must be followed by the disappearance of adventitial inflammation visualized by metabolic activity in FDG-PET 18FDG uptake and a normalization of biological markers of the injury Conversely the inefficacy of endovascular therapy should result in the persistence of an inflammatory metabolic activity in relation to the saccular endoleak and a persistent elevation of plasma biomarkers
Primary objective
The general aim of this pilot study is to assess the effect of endoprosthesis treatment on PET scan functional imaging of AAA
Materials and method
Seven French Hospitals will recruit 50 patients presenting a large AAA scheduled for EVAR Endovascular prosthesis within one month A 18FDG PET scan will be added to their conventional follow up CT scan usual blood sampling ECG ie within one month before endovascular surgery inclusion visit at one month and 6 month of follow-up
Furthermore biological markers of the inflammation proteolysis and coagulation potentially related to morphology and evolution of AAA will be investigated by the U698 National Institute for Medical Research Unit implementing already existing database from others cohorts of patients with AAA including biological samples conserved both by the Nancy clinical investigation center and the U698 National Institute for Medical Research Unit
Study duration for a patient 26 months
Perspectives
This pilot study will help to assess the effect of EVAR in terms of it functional inflammatory response and determine the required sample size for a future project Since aneurysm expansion rate varies widely among patients and even for one single patient over time studying metabolic adventitial immuno-inflammatory activity using 18FDG PET imaging will provide new major informations about the efficacity of endovascular therapy in AAA Plasma assays will help to identify intermediate biological markers of aneurysm evolutivity after endovascular therapy Those complementary functional and biological criteria are of paramount importance to improve therapeutic management and prognosis of AAA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None