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

Primary Purpose

Aortic Aneurysm

Status
Withdrawn
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
lupiae technique
lupiae technique
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm focused on measuring lupiae techinque, aortic aneurism, aortic dissection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Policlinico S Orsola Malpighi

Outcomes

Primary Outcome Measures

all cause mortality

Secondary Outcome Measures

Full Information

First Posted
April 20, 2010
Last Updated
June 27, 2011
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT01107366
Brief Title
ATLANTIS:Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal Aneurysms Repair With LupiAe Hybrid TechNique
Acronym
ATLANTIS
Official Title
Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Withdrawn
Why Stopped
The study never started since our Medical Ethic Commeettee did not approved it
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: surgical arch reconstruction with a Dacron multibranched surgical prothesis endovascular implantation of a thoracic stent graft

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm
Keywords
lupiae techinque, aortic aneurism, aortic dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
lupiae technique
Intervention Description
it's a new hybrid technique for the treatment of aortic aneurism and dissection.
Intervention Type
Procedure
Intervention Name(s)
lupiae technique
Intervention 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
Primary Outcome Measure Information:
Title
all cause mortality
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Policlinico S Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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