Ignite Creation Date:
2024-05-06 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03608683
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2018-07-11
Brief Title:
Evaluation of the Treatment of Abdominal Aortic Pathology With Hostile Necks Para-Juxra-renal and Sovrarenal Pathology at Short Mid and Long Term
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Evaluation of Open Surgical Treatment of Abdominal Aortic Pathology With Hostile Necks Para-Juxra-renal and Sovrarenal Pathology at Short Mid and Long Term
Status:
COMPLETED
Status Verified Date:
2023-02
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:
p-AAA
Brief Summary:
Although open repair OR is currently reported as the gold standard of treatment fenestrated endovascular repair FEVAR is being increasingly applied for the treatment of proximal abdominal aortic aneurysms p-AAA such as hostile-necked juxta- para- and supra-renal aortic aneurysms1 Nevertheless advantages of FEVAR in terms of lowering postoperative complications should be balanced with the need of both complex device configurations and operators with large endovascular expertise The aim of this study is to report the experience of Data from patients treated will be prospectively collected All post-operative results will be recorded Major adverse event MAE are defined as the presence of one of the following all-cause mortality bowel ischemia myocardial infarction paraplegia respiratory failure stroke and renal insufficiency
Furthermore the pre-operative contrast-enhanced computed tomography scans CTA of all patients stored in the hospital PACS will be analyzed on the dedicated workstation with OsiriX software Pixmeo sarl Bernex Switzerland currently employed in our Unit for imaging assessment
Patients will undergo standard control with the execution of a Doppler ultrasound and creatinine serum levels at 1 6 12 24 36 48 and 60 months A CTA will also be performed at 12 months as per standard clinical practice
of p-AAA treatment
Furthermore the pre-operative contrast-enhanced computed tomography scans CTA of all patients stored in the hospital PACS will be analyzed on the dedicated workstation with OsiriX software Pixmeo sarl Bernex Switzerland currently employed in our Unit for imaging assessment
Patients will undergo standard control with the execution of a Doppler ultrasound and creatinine serum levels at 1 6 12 24 36 48 and 60 months A CTA will also be performed at 12 months as per standard clinical practice
of p-AAA treatment
Detailed Description:
Primary end-point is to evaluate the mortality and major adverse events MAE at 30 days 2 years and 5 years prospectively in the cohort of patients p-AAA treated by means of open repair in the next 100 patients that will be treated between 2018 and 2020 in the Vascular Surgery Unit of the San Raffaele Hospital
Data from patients treated will be prospectively collected All post-operative results will be recorded Major adverse event MAE are defined as the presence of one of the following all-cause mortality bowel ischemia myocardial infarction paraplegia respiratory failure stroke and renal insufficiency
Patients will undergo standard control with the execution of a Doppler ultrasound and creatinine serum levels at 1 6 12 24 36 48 and 60 months A CTA will also be performed at 12 months as per standard clinical practice The 100 patients that will be enrolled until December 2020 will also sign an ad hoc consents specific for this study
Sensitive patient information will not be available during data analysis The clinical study will be carried out according to the ethical principles of the Declaration of Helsinki and following the active regulations on observational studies
Expected results are
death at 30 days 2
any MAE at 30 day 25 Patients characteristics and anatomical data on the visceral vessels will be analyzed on Wizard Statistics software to investigate the presence of statistically significant Pearson correlations among the identified variables
Data from patients treated will be prospectively collected All post-operative results will be recorded Major adverse event MAE are defined as the presence of one of the following all-cause mortality bowel ischemia myocardial infarction paraplegia respiratory failure stroke and renal insufficiency
Patients will undergo standard control with the execution of a Doppler ultrasound and creatinine serum levels at 1 6 12 24 36 48 and 60 months A CTA will also be performed at 12 months as per standard clinical practice The 100 patients that will be enrolled until December 2020 will also sign an ad hoc consents specific for this study
Sensitive patient information will not be available during data analysis The clinical study will be carried out according to the ethical principles of the Declaration of Helsinki and following the active regulations on observational studies
Expected results are
death at 30 days 2
any MAE at 30 day 25 Patients characteristics and anatomical data on the visceral vessels will be analyzed on Wizard Statistics software to investigate the presence of statistically significant Pearson correlations among the identified variables
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