Clinical trial NCT06012123: BS-CERAB TECHNIQUE
Official title: COMBINATION OF BEGRAFT AND SOLARIS STENTGRAFTS FOR THE COVERED ENDOVASCULAR RECONSTRUCTION OF AORTIC BIFURCATION (BS-CERAB) TECHNIQUE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortoiliac Occlusive Disease
Stent Complication
Vascular Device Occlusion
Iliac Artery Stenosis
Lead sponsor: Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Sponsor class: NETWORK
First posted: 2023-08-25
Enrollment: 21
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that underwent endovascular treatment of atherosclerotic steno-occlusive aorto-iliac lesions between January 2020 and June 2023.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary patency
timeFrame: 12 months
Secondary outcomes:
measure: Primary-assisted patency
timeFrame: 12 months
measure: Secondary patency
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Amputation rate
timeFrame: 12 months
measure: Clinical status
timeFrame: 12 months
measure: ABI measurements
timeFrame: 12 months
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Valladolid Univeristy Hospital
Study officials:
References: