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

June 27, 2011 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal

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)

Study Overview

Status

Withdrawn

Conditions

Aortic Aneurysm

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Bologna, Italy, 40138
    - Policlinico S Orsola Malpighi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all cause mortality Time Frame: 12 months	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria