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
Not provided
Not provided
Not provided
Since the development of multibranched endografts a novel therapeutic option for the management of thoracoabdominal and para-renal aortic aneurysms was made accessible. The introduction of readily available off-the-shelf devices expanded the application of such technology also to those patients who could not afford to wait for a customized endograft to be designed and manufactured according to their aneurysm morphology
To evaluate the theoretical anatomical feasibility of multibranched off-the-shelf endografts in patients with thoracoabdominal and para-renal aortic aneurysms based on retrospective review of pre-operative imaging studies of the patients treated for this pathology in the San Raffaele Hospital's Vascular Surgery Unit in the past ten years.
Materials and methods:
The investigators review retrospectively the pre-operative contrast-enhanced computed tomography scans (CTA), stored in the hospital PACS, of the 562 patients treated at the San Raffaele Hospital's Vascular Surgery Unit, between January 2007 and January 2017 by means of open aortic aneurysm repair. All patients involved in the study have already signed informed consent for data collection and analysis at hospital admission.
Inclusion criteria:
• patient who underwent treatment of thoracoabdominal or para-renal aortic aneurysm at San Raffaele Hospital in between January 2007 and January 2017.
Exclusion criteria:
• incomplete or inappropriate imaging quality defined as pre-operative CTAs with slice thickness >1-mm.
All preoperative CTAs with 1-mm slice thickness will be included in the study and analyzed on the dedicated workstation with OsiriX software (Pixmeo sarl, Bernex, Switzerland) currently employed in the Unit for imaging assessment.
Sensitive patient information will not be available during data analysis.
Vascular access will be evaluated according to the following inclusion criteria:
The proportion of patients excluded due to inadequate vascular accesses will be reported in the final results together with diameter of the smallest access vessels determining the exclusion.
The selected patient sample will be subdivided in three groups:
The latest 100 consecutive cases per group will be subsequently studied in order to assess the feasibility of an off-the-shelf endovascular approach.
Multi-planar and curved reconstruction of each patient CTA will be analyzed and the following measurements recorded using the top of the ostium of the celiac trunk as reference point:
The feasibility will be evaluated considering the patients and endografts characteristics and all the technical steps required for a proper endovascular aneurysm exclusion.
All the assessed variables will be prospectively recorded in a Microsoft Office Excel database.
The clinical study will be carried out according to the ethical principles of the Declaration of Helsinki and following the active regulations on observational studies.
Analysis:
The extracted data will be employed to feed three major lines of research:
The results of the three studies will be submitted for publication in peer-reviewed scientific journals focused on the field of vascular and endovascular surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| anatomical feasibility of multibranched off-the-shelf endografts in patients with thoracoabdominal and para-renal aortic aneurysms | evaluate the theoretical anatomical feasibility of multibranched off-the-shelf endografts in patients with thoracoabdominal and para-renal aortic aneurysms based on retrospective review of pre-operative imaging studies of the patients treated for this pathology in our Unit in the past ten years | 2007-2017 |
Not provided
Not provided
Inclusion criteria:
• patient who underwent treatment of thoracoabdominal or para-renal aortic aneurysm at San Raffaele Hospital in between January 2007 and January 2017.
Exclusion criteria:
• incomplete or inappropriate imaging quality defined as pre-operative CTAs with slice thickness >1-mm
Not provided
Not provided
Not provided
patient who underwent treatment of thoracoabdominal or para-renal aortic aneurysm at San Raffaele Hospital in between January 2007 and January 2017.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Hospital | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17980540 | Result | Chuter TA, Rapp JH, Hiramoto JS, Schneider DB, Howell B, Reilly LM. Endovascular treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2008 Jan;47(1):6-16. doi: 10.1016/j.jvs.2007.08.032. Epub 2007 Nov 5. | |
| 22545880 | Result | Sobocinski J, d'Utra G, O'Brien N, Midulla M, Maurel B, Guillou M, Azzaoui R, Roeder B, Resch TA, Haulon S. Off-the-shelf fenestrated endografts: a realistic option for more than 70% of patients with juxtarenal aneurysms. J Endovasc Ther. 2012 Apr;19(2):165-72. doi: 10.1583/11-3772.1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 32360681 | Derived | Cambiaghi T, Grandi A, Bilman V, Melissano G, Chiesa R, Bertoglio L. Anatomic feasibility of the investigational GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE), off-the-shelf multibranched endograft for the treatment of pararenal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2021 Jan;73(1):22-30. doi: 10.1016/j.jvs.2020.03.056. Epub 2020 Apr 28. |