Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 â„¢ Coselli Thoracoabdominal Grafts.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAAA spinal loop graft | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms | Device | 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 â„¢ Coselli Thoracoabdominal Grafts. |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants who obtain technical success | number of surviving participants | 12 month |
| incidence of thrombosis of the prosthetic branches, visceral arteries and replanted intercostal arteries | freedom from thrombosis of the prosthetic branches,visceral arteries and replanted intercostal arteries | 12 month |
| incidence of aneurysmal dilatation of visceral and replanted intercostal arteries | freedom from surgical / endovascular reoperation for aneurysmal dilatation of visceral and replanted intercostal arteries | 12 month |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
• patients aged ≤ 18 years
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Hospital | Milan | 20132 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D017545 | Aortic Aneurysm, Thoracic |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D001018 |
| Aortic Diseases |