ATLANTIS:Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal Aneurysms Repair With LupiAe Hybrid TechNique
| Tracking Information | |
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| First Received Date ICMJE | April 20, 2010 |
| Last Updated Date | June 27, 2011 |
| Start Date ICMJE | June 2010 |
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
all cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01107366 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | ATLANTIS:Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal Aneurysms Repair With LupiAe Hybrid TechNique |
| Official Title ICMJE | Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal |
| Brief Summary | To prospectively evaluate the safety and efficacy of the LUPIAE hybrid technique for the treatment of
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| Detailed Description | LUPIAE technique: Hybrid repair of thoracic or thoraco-abdominal aneurysms of different etiology and type A dissections with a two-stage procedure:
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| Study Type ICMJE | Interventional |
| Study Phase | Phase 4 |
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | Aortic Aneurysm |
| Intervention ICMJE |
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| Study Arm (s) | Not Provided |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Withdrawn |
| Estimated Enrollment ICMJE | 120 |
| Estimated Completion Date | December 2012 |
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Italy |
| Administrative Information | |
| NCT Number ICMJE | NCT01107366 |
| Other Study ID Numbers ICMJE | ATLANTIS BOLOGNA |
| Has Data Monitoring Committee | No |
| Responsible Party | prof roberto di bartolomeo, cardiochirurgia |
| Study Sponsor ICMJE | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi |
| Verification Date | June 2011 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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