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

This study has been withdrawn prior to enrollment.
(The study never started since our Medical Ethic Commeettee did not approved it)
Sponsor:
Information provided by:
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier:
NCT01107366
First received: April 20, 2010
Last updated: June 27, 2011
Last verified: June 2011

April 20, 2010
June 27, 2011
June 2010
December 2012   (final data collection date for primary outcome measure)
all cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01107366 on ClinicalTrials.gov Archive Site
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ATLANTIS:Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal Aneurysms Repair With LupiAe Hybrid TechNique
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)

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
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Aneurysm
  • Procedure: lupiae technique
    it's a new hybrid technique for the treatment of aortic aneurism and dissection.
  • 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
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
120
December 2012
December 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01107366
ATLANTIS BOLOGNA
No
prof roberto di bartolomeo, cardiochirurgia
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Not Provided
Not Provided
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP