Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03213795 |
| Other study ID # |
TAMBE/39/OSR |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 12, 2017 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
February 2020 |
| Source |
IRCCS San Raffaele |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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
Description:
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:
1. femoral and iliac artery diameter ≥8mm (24Fr) on one side and ≥5mm (16Fr) on the
contralateral side, without severe calcification or tortuosity;
2. at least one patent vessel for anterograde branch cannulation
(branchial/axillary/subclavian artery) with diameter ≥3mm.
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:
1. extensive TAAA: including Crawford extent I and II TAAA;
2. Crawford extent III TAAA;
3. supra-renal aortic aneurysms: including Crawford extent IV TAAA and para-renal abdominal
aortic aneurysms.
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:
1. patency of the target vessels (CT, SMA, LRA and RRA);
2. presence of accessory renal arteries or independent origin of celiac trunk branches;
3. inner diameter of the target vessels;
4. target vessels with aberrant or early branching, aneurysm or dissection, with <15mm of
healthy artery for bridging stent placement;
5. radial orientation of the target vessels ("clock position", expressed in degrees);
6. orientation of the target vessels with respect to the longitudinal aortic axis
(expressed in degrees);
7. distance to the top of the ostium of target vessels;
8. distance to aortic bifurcation and bilateral iliac bifurcation;
9. aneurysmatic involvement of common iliac arteries (max diameter >20mm);
10. distance to proximal aneurysm neck (25mm of healthy aorta);
11. distance to left subclavian artery;
12. inner and outer diameter at proximal neck, at 1cm and 2cm above proximal neck, at aortic
bifurcation, and at common iliac artery bilaterally;
13. residual aortic lumen at CT, SMA and renal arteries emergence.
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:
1. to evaluate the anatomical suitability of the novel investigational Gore TAMBE (W.L.
Gore & Associates, Flagstaff, AZ, USA) multibranched off-the-shelf stent-graft for total
endovascular management of thoracoabdominal and para-renal aortic aneurysms;
2. to evaluate the anatomical suitability, according to Instruction for Use and literature
recommendations, of the commercially available Cook T-Branch (Cook Medical, Bloomington,
IN, USA) multibranched off-the-shelf stent-graft for total endovascular management of
thoracoabdominal and para-renal aortic aneurysms. This line of research will focus on
the evaluation of the expected length of healthy aorta sacrificed to obtain appropriate
proximal endograft sealing;
3. to compare the applicability of Gore TAMBE and Cook T-Branch endografts in TAAA of
different extents and para-renal aneurysms.
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.
