BS-CERAB TECHNIQUE

Completed

• Conditions: Aortoiliac Occlusive Disease; Vascular Device Occlusion; Iliac Artery Stenosis; Stent Complication

• Registration Number: NCT06012123
• Lead Sponsor: Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-07-30
• Status Verified: 2023-08
• Study Completion: 2023-08-15
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Last Update Submitted: 2023-08-21
• Study First Posted: 2023-08-25
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Patients with lifestyle-limiting intermittent claudication, ischemic rest pain, ischemic ulcers or gangrene (Rutherford class 3 to 6) who presented steno-occlusive disease of the aortic bifurcation undergoing endovascular treatment by CERAB and PTA/covered stenting of iliac arteries

Exclusion Criteria

• Patients who could not receive antiplatelet or anticoagulation therapies.
• Patients with concomitant aneurysm of the aorta, acute thrombus, unsalvageable limb or very limited life-expectancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary patency	12 months	Absence of binary restenosis or reocclusion on duplex ultrasound examination without repeat target lesion interventions

Secondary Outcome Measures

Name	Time	Method
Primary-assisted patency	12 months	Patent aoto-iliac segment that underwent further intervention within the inflow, treated vessel segment, or outflow of the treated vessel segment to improve patency
Clinical status	12 months	Rutherford scale
ABI measurements	12 months	Ankle-Brachial index
Secondary patency	12 months	Requiring a secondary intervention to restore patency after occlusion of the treated segment. Secondary interventions include PTA, drug-eluting balloon PTA (DEB-PTA), additional stent placement or surgical bypass based on clinical deterioration.
Mortality	12 months
Amputation rate	12 months	Major and minor amputation rate

Trial Locations

Locations (1)

Valladolid Univeristy Hospital; 🇪🇸 Valladolid, Spain