ATLANTIS:Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal Aneurysms Repair With LupiAe Hybrid TechNique

Study Overview
=================
Brief Summary
-----------------
To prospectively evaluate the safety and efficacy of the LUPIAE hybrid technique for the treatment of thoracic or thoraco-abdominal aortic aneurysms thoracic aortic type A dissections 2. to compare the safety and efficacy of the LUPIAE hybrid technique with historical groups (literature review, other hybrid techniques, LUPIAE retrospective patients)

Detailed Description
-----------------
LUPIAE technique: Hybrid repair of thoracic or thoraco-abdominal aneurysms of different etiology and type A dissections with a two-stage procedure: surgical arch reconstruction with a Dacron multibranched surgical prothesis endovascular implantation of a thoracic stent graft

Official Title
-----------------
Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal

Conditions
-----------------
Aortic Aneurysm

Intervention / Treatment
-----------------
* Procedure: lupiae technique
* Procedure: lupiae technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient willing to sign the informed consent, or In case of acute patients that should arrive at the hospital in unconsciousness status, patient's first degree relatives willingness to sign the informed consent and patient's willingness to re-consent for the study participation once he/she is again conscious. and Patients with extensive thoracic or thoraco-abdominal aortic aneurysms (>55 mm diameter), involving the ascending, arch and descending aortic segments, but not involving the renal arteries (at least 15 mm of healthy tissue above the most proximal renal artery). Or Patients with extensive type A aortic dissection (DeBakey type I) with at least one of the following minimum criteria: An initial false lumen diameter measured in the upper descending thoracic aorta >22 mm; Total aortic diameter measured in the descending thoracic aorta >45 mm; True lumen's compression (True lumen <10% of total aortic lumen); Non-controlled hypertension; Persistent pain; Rupture or imminent rupture; Exclusion Criteria: Patient has a standard contraindication to the implant of thoracic stent graft; Patient unable to commit to follow-up schedule; Patient has medical conditions that preclude protocol required testing or limit study participation; Patient is enrolled or intend to participate in another clinical trial during the course of this study; Less than 18 years of age; Pregnancy; A life expectancy of less than one year, except for Patients with extensive type A aortic dissection (DeBakey type I)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: lupiae technique|it's a new hybrid technique for the treatment of aortic aneurism and dissection.|
|Procedure: lupiae technique|LUPIAE technique Hybrid repair of thoracic or thoraco-abdominal aneurysms of different etiology and type A dissections with a two-stage procedure: surgical arch reconstruction with a Dacron multibranched surgical prothesis endovascular implantation of a thoracic stent graft|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lupiae techinque, aortic aneurism, aortic dissection