BS-CERAB TECHNIQUE

Iliac Artery Stenosis Clinical Trial

— BS-CERAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06012123
• Other study ID #: PI23-0005
• Status: Completed
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 15, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortoiliac Occlusive Disease
• Iliac Artery Stenosis
• Stent Complication

Intervention

Procedure:
• Aortoiliac angioplasty and stenting
Covered endovascular reconstruction of aortic bifurcation (CERAB) in patient with aorto-iliac occlusive disease

Locations

Country	Name	City	State
Spain	Valladolid Univeristy Hospital	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency	Absence of binary restenosis or reocclusion on duplex ultrasound examination without repeat target lesion interventions	12 months
Secondary	Primary-assisted patency	Patent aoto-iliac segment that underwent further intervention within the inflow, treated vessel segment, or outflow of the treated vessel segment to improve patency	12 months
Secondary	Secondary patency	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.	12 months
Secondary	Mortality		12 months
Secondary	Amputation rate	Major and minor amputation rate	12 months
Secondary	Clinical status	Rutherford scale	12 months
Secondary	ABI measurements	Ankle-Brachial index	12 months