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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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention Phase
Aortic Aneurysm
Procedure: lupiae technique
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: June 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107366

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

No publications provided

Responsible Party: prof roberto di bartolomeo, cardiochirurgia
ClinicalTrials.gov Identifier: NCT01107366     History of Changes
Other Study ID Numbers: ATLANTIS BOLOGNA
Study First Received: April 20, 2010
Last Updated: June 27, 2011
Health Authority: Italy: Ethics Committee

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
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014