Aortic Aneurysm
Conditions
Keywords
lupiae techinque, aortic aneurism, aortic dissection
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)
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
Interventions
PROCEDURElupiae technique
it's a new hybrid technique for the treatment of aortic aneurism and dissection.
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all cause mortality | 12 months |
Countries
Italy
Outcome results
None listed