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

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ClinicalTrials.gov Identifier: NCT01107366
Recruitment Status : Withdrawn (The study never started since our Medical Ethic Commeettee did not approved it)
First Posted : April 21, 2010
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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)

Condition or disease Intervention/treatment Phase
Aortic Aneurysm Procedure: lupiae technique Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal
Study Start Date : June 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    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


Primary Outcome Measures :
  1. all cause mortality [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107366


Locations
Italy
Policlinico S Orsola Malpighi
Bologna, Italy, 40138
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Responsible Party: prof roberto di bartolomeo, cardiochirurgia
ClinicalTrials.gov Identifier: NCT01107366     History of Changes
Other Study ID Numbers: ATLANTIS BOLOGNA
First Posted: April 21, 2010    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011

Keywords provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
lupiae techinque
aortic aneurism
aortic dissection

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases