ATLANTIS:Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal Aneurysms Repair With LupiA… (NCT01107366) | Clinical Trial Compass
WithdrawnPhase 4
ATLANTIS:Extensive Type A Dissections and Thoracic/ Thoraco-Abdominal Aneurysms Repair With LupiAe Hybrid TechNique
Stopped: The study never started since our Medical Ethic Commeettee did not approved it
Italy120 participantsStarted 2010-06
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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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.
✓. 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).
✓. Patients with extensive type A aortic dissection (DeBakey type I) with at least one of the following minimum criteria:
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;
What they're measuring
1
all cause mortality
Timeframe: 12 months
Trial details
NCT IDNCT01107366
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna