BS-CERAB TECHNIQUE — BS-CERAB  

Iliac Artery Stenosis Clinical Trial

Official title: COMBINATION OF BEGRAFT AND SOLARIS STENTGRAFTS FOR THE COVERED ENDOVASCULAR RECONSTRUCTION OF AORTIC BIFURCATION (BS-CERAB) TECHNIQUE

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Aortoiliac Occlusive Disease
• Iliac Artery Stenosis
• Stent Complication

• NCT number: NCT06012123
• Study type: Observational [Patient Registry]
• Source: Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
• Status: Completed
• Start date: January 1, 2023
• Completion date: August 15, 2023