MuLtibranchEd Graft for OPen RepAir of ThoRacoabdominal Aneurysms
Not Applicable
Completed
- Conditions
- Aneurysm AbdominalAneurysm Thoracic
- Interventions
- Device: branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms
- Registration Number
- NCT04430114
- Lead Sponsor
- IRCCS San Raffaele
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TAAA spinal loop graft branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
San Raffaele Hospital
🇮🇹Milano, Italy