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

Aortic Aneurysm Clinical Trial

— ATLANTIS  

Official title:

Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01107366
• Other study ID #: ATLANTIS BOLOGNA
• Status: Withdrawn
• Phase: Phase 4
• First received: April 20, 2010
• Last updated: June 27, 2011
• Start date: June 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2011
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm

Intervention

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

Locations

Country	Name	City	State
Italy	Policlinico S Orsola Malpighi	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		12 months	Yes