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

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• Status: Withdrawn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: Procedure: lupiae technique; Procedure: lupiae technique

Detailed Description

LUPIAE technique:

Hybrid repair of thoracic or thoraco-abdominal aneurysms of different etiology and type A dissections with a two-stage procedure:

1. surgical arch reconstruction with a Dacron multibranched surgical prothesis
2. endovascular implantation of a thoracic stent graft

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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

2. 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

3. 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:

1. Patient has a standard contraindication to the implant of thoracic stent graft;
2. Patient unable to commit to follow-up schedule;
3. Patient has medical conditions that preclude protocol required testing or limit study participation;
4. Patient is enrolled or intend to participate in another clinical trial during the course of this study;
5. Less than 18 years of age;
6. Pregnancy;
7. A life expectancy of less than one year, except for Patients with extensive type A aortic dissection (DeBakey type I)

Study Plan

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	12 months

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

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: April 20, 2010
• First Posted (ESTIMATE): April 21, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 28, 2011
• Last Update Submitted That Met QC Criteria: June 27, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: aortic dissection; lupiae techinque; aortic aneurism
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: ATLANTIS BOLOGNA