Aneurysm Abdominal, Aneurysm Thoracic
Conditions
Brief summary
The objective of the study is the evaluation of the technical success and clinical outcomes of the surgical treatment of thoraco-abdominal aortic aneurysms treated by Jotec TAAA spinal loop graft custom made CE equivalent branched prosthesis, compared with the patient cohort already treated with standard and / or bench-top prostheses Gelweave ™ Coselli Thoracoabdominal Grafts.
Interventions
DEVICEbranched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms
Jotec TAAA spinal loop graft custom made CE equivalent branched prosthesis, compared with the cohort of patients already treated with standard prostheses and / or Gelweave ™ Coselli Thoracoabdominal Grafts.
Sponsors
IRCCS San Raffaele
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients aged ≥ 18 years; * patients candidates for surgical treatment of thoraco-abdominal aorta of the II and III type sec. Crawford using TAAA spinal loop graft custom made CE equivalent prosthesis
Exclusion criteria
• patients aged ≤ 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of participants who obtain technical success | 12 month | number of surviving participants |
| incidence of thrombosis of the prosthetic branches, visceral arteries and replanted intercostal arteries | 12 month | freedom from thrombosis of the prosthetic branches,visceral arteries and replanted intercostal arteries |
| incidence of aneurysmal dilatation of visceral and replanted intercostal arteries | 12 month | freedom from surgical / endovascular reoperation for aneurysmal dilatation of visceral and replanted intercostal arteries |
Countries
Italy
Outcome results
None listed