Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06012123 |
| Other study ID # |
PI23-0005 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
August 15, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The covered endovascular reconstruction of aortic bifurcation (CERAB) technique was described
l in 2013 to reconstruct the aortic bifurcation in a more anatomical and physiological way.
With the use of this technique, a covered stent is expanded 15 to 20 mm above the aortic
bifurcation and this stent is proximally adapted to the aortic wall with a larger balloon,
thereby creating a cone-shaped stent. Two iliac covered stents are then placed in the distal
conic segment and simultaneously inflated, making a tight connection with the aortic stent,
as if they were molded together, thus simulating a new bifurcation. This minimal invasive
endovascular technique using covered stents, was developed in order to optimize endovascular
mimicking the anatomical configuration of the aortic bifurcation and in an attempt to
overcome the disadvantages of kissing stents influenced by geometric factors such as radial
mismatch, protrusion mismatch and stent conformation. The use of BeGraft (balloon-expandalbe
covered stent) and Solaris (self-expandable covered stent) fro this technique is revised.
Description:
The covered endovascular reconstruction of aortic bifurcation (CERAB) technique was described
l in 2013 to reconstruct the aortic bifurcation in a more anatomical and physiological way.
With the use of this technique, a covered stent is expanded 15 to 20 mm above the aortic
bifurcation and this stent is proximally adapted to the aortic wall with a larger balloon,
thereby creating a cone-shaped stent. Two iliac covered stents are then placed in the distal
conic segment and simultaneously inflated, making a tight connection with the aortic stent,
as if they were molded together, thus simulating a new bifurcation.
This minimal invasive endovascular technique using covered stents, was developed in order to
optimize endovascular mimicking the anatomical configuration of the aortic bifurcation and in
an attempt to overcome the disadvantages of kissing stents influenced by geometric factors
such as radial mismatch, protrusion mismatch and stent conformation.
The use of BeGraft (balloon-expandalbe covered stent) and Solaris (self-expandable covered
stent) fro this technique is revised.
A retrospective study included patients that underwent endovascular treatment of
atherosclerotic steno-occlusive aorto-iliac lesions between January 2020 and June 2023. The
study, which received no financial support from industry, was performed in agreement with the
Declaration of Helsinki and was approved by our institutional review boards. In accordance
with institutional and local regulatory policies, this retrospective review of de-identified
procedural and follow-up data was exempt from informed consent.
