DediCated MuLtibranchEd DacrOn Graft for OPen RepAir of ThoRacoabdominal Aneurysms - CLEOPATRA Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aneurysm Abdominal
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- number of participants who obtain technical success
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Bertoglio Luca
Principal Investigator
IRCCS San Raffaele
Eligibility Criteria
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
Outcomes
Primary Outcomes
number of participants who obtain technical success
Time Frame: 12 month
number of surviving participants
incidence of thrombosis of the prosthetic branches, visceral arteries and replanted intercostal arteries
Time Frame: 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
Time Frame: 12 month
freedom from surgical / endovascular reoperation for aneurysmal dilatation of visceral and replanted intercostal arteries