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

NCT01107366 | Withdrawn Phase 4

• 1 other identifier: ATLANTIS BOLOGNA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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)

Conditions

Aortic Aneurysm

Keywords

lupiae techinque; aortic aneurism; aortic dissection

Outcome Measures

Primary Outcomes (1)

• all cause mortality

  12 months

Interventions

lupiae technique PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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;

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Policlinico S Orsola Malpighi

Bologna, Italy, 40138, Italy

Location

MeSH Terms

Conditions

Aortic Aneurysm; Aortic Dissection

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 21, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

IT (1)