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

NCT ID: NCT01107366

Last Updated: 2011-06-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-12-31

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:

1. surgical arch reconstruction with a Dacron multibranched surgical prothesis

2. endovascular implantation of a thoracic stent graft

Conditions

Aortic Aneurysm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

lupiae technique

it's a new hybrid technique for the treatment of aortic aneurism and dissection.

Intervention Type: 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:

1. surgical arch reconstruction with a Dacron multibranched surgical prothesis

2. endovascular implantation of a thoracic stent graft

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

cardiochirurgia

Locations

Policlinico S Orsola Malpighi

Bologna, Italy, Italy

Countries

Italy

Other Identifiers

ATLANTIS BOLOGNA

Identifier Type: -

Identifier Source: org_study_id