Aortic Aneurysm Clinical Trial
Official title:
Medical & Economical Evaluation of Endovascular Therapy of Complex Thoracal Abdominal Aneurysms (Type 1-3 Thoracal Abdominal Aneurysms) by Fenestrated & Branched Stent-grafts
The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and 3 thoracal abdominal aortic aneurysms.
The aim of this study is to prospectively compare the perioperative mortality severe
morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and
3 thoracal abdominal aortic aneurysms.
The primary goal of the study is to demonstrate a significant drop in 30-day mortality and
life threatening morbidity in the endovascular arm of the study. Our hypothesis, derived
from the literature, that the average 30-days mortality is 3% after endovascular repair and
10% after open surgery justifies the design of a prospective study between endovascular
therapy (50 patients (amendment n.5 - 9/07/2013) treated in 5 University hospitals with
significant experience of the technique) and open repair (220 similar patients analyzed from
the national database of the MOH).
In-hospital morbidity are similarly expected to be lower in the endovascular group. The
investigators also wish to demonstrate that endovascular repair does not represent a
significant overcost, as compared to open repair. The cost of the implantable medical device
(IMD), of follow-up screening, and of eventual repeated interventions should be compensated
by a reduced stay in intensive care unit ICU, and by a reduced in-hospital length of stay.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04149600 -
Identification of Genetic Causes of Calcific Aortic Valve Disease
|
||
| Enrolling by invitation |
NCT04035356 -
HAART Annuloplasty Device Valve Repair Registry
|
||
| Recruiting |
NCT02729064 -
Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose
|
Phase 1 | |
| Completed |
NCT02467062 -
Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease.
|
N/A | |
| Completed |
NCT02283307 -
Dual Energy CT Urography With Reduced Iodinated Contrast
|
N/A | |
| Completed |
NCT01678261 -
X-chromosome Inactivation, Epigenetics and the Transcriptome
|
N/A | |
| Terminated |
NCT01055275 -
Cook Iliac Branch Graft Post-market Registry
|
N/A | |
| Completed |
NCT00615888 -
Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair
|
N/A | |
| Completed |
NCT03510793 -
Microcirculation and Anesthesia in Vascular Surgery
|
||
| Completed |
NCT03207568 -
RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)
|
N/A | |
| Recruiting |
NCT05073991 -
Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.
|
||
| Not yet recruiting |
NCT01918969 -
Reference Values of Circulating Endothelial Progenitor Cells
|
N/A | |
| Not yet recruiting |
NCT01918982 -
Circulating Endothelial Progenitor Cells and Aortic Aneurysm
|
N/A | |
| Completed |
NCT02000544 -
Clinical Evaluation of a Modular Extracorporeal Circulation Circuit
|
N/A | |
| Completed |
NCT01256372 -
An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery
|
Phase 2 | |
| Recruiting |
NCT00661518 -
PET/CT Imaging of Aneurysm Wall Inflammation
|
N/A | |
| Completed |
NCT00094575 -
Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA)
|
Phase 4 | |
| Recruiting |
NCT04471909 -
NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
|
N/A | |
| Recruiting |
NCT05603520 -
Phenotyping Heterogeneity and Regionality of the Aorta
|
||
| Completed |
NCT03727542 -
Influence of Short AV Delay Permanent Pacing on Matrix Metalloproteinase Levels
|
N/A |