Aortoiliac Occlusive Disease Clinical Trial
Official title:
Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) Technique for Extensive Aortoiliac Occlusive Disease
To evaluate the safety and efficacy of the CERAB technique as an alternative to surgical reconstruction for treatment of aorto-iliac occlusive disease.
According to the Trans-Atlantic Inter-society Consensus (TASC-II), bypass grafting is the
treatment of choice for extensive aortoiliac occlusive disease (AIOD) due to the good
long-term patency rates. However, surgical reconstruction is associated with peri-operative
morbidity and mortality.
Kissing stent technique was introduced as an endovascular treatment alternative for bilateral
aortoiliac occlusive disease in 1991. Reported technical success rates varied with the use of
bare metal stents in extensive AOID.
The COBEST trial showed that covered balloon expandable stents (CBES) have a superior primary
patency rate and clinical improvement outcome at 24 months when compared with bare metal
stents. CBES may immediately reduce the risk of procedural complications such as dissection,
perforation, in-stent stenosis, and embolization.
In 2013, CERAB technique was introduced to improve endovascular treatment results by a more
anatomical and physiological reconstruction, with a subsequent better clinical outcome.
The CERAB technique was developed to overcome the anatomical and physiological disadvantages
of kissing stents such as flow disturbances leading to turbulence and stasis of blood, which
may cause thrombus formation and intimal neohyperplasia.
The early results of the CERAB configuration are promising at 1-year follow up in a group of
130 patients with AOID and the 30-day major complication rate was 7.7%.
CERAB and Chimney CERAB (C-CERAB) techniques may change the treatment algorithm of AIOD and
juxta-renal occlusive disease. It appears to be a safe and feasible alternative with
promising results, being a valid alternative for surgery and/or kissing stents.
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