Aorto-Iliac Atherosclerosis Clinical Trial
Official title:
Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) for Extensive Aortoiliac Occlusive Disease A Multicenter, Prospective Investigator Initiated Trial
Endovascular treatment is rapidly taking over surgery for aorto-iliac occlusive disease
(AOID), also in extensive pathology. This is related to its minimally invasiveness,
decreasing the procedural morbidity rate. When the aortic bifurcation was involved in the
lesion, the patency rates of kissing stents configurations were often inferior to open
repair. In 2013 the Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB)
technique was introduced in an attempt to improve endovascular treatment results by a more
anatomical and physiological reconstruction, with a subsequent improved clinical outcome.
This investigator-initiated multicenter trial will prospectively record all data on performed
CERAB procedures using the Bentley balloon expandable covered stents (BeGraft Aortic and
BeGraft Peripheral) in multiple International sites, in order to gain more robust real-world
data on the efficacy of these stent grafts for this indication.
Consecutive patients in whom a CERAB will be performed with these particular covered stents
in the participating centers.
Main study parameters/endpoints: The primary end-point of this study is technical success.
Patency rates, peri-procedural morbidity, clinical improvement, quality of life,
clinically-driven target vessel revascularization and reintervention-rate will be secondary
outcome measures. Overall, patients will be followed for 5 years
Endovascular treatment is rapidly taking over surgery for aorto-iliac occlusive disease
(AOID) also for complex lesions. This is related to the minimally invasiveness of the
procedure decreasing the morbidity rate. Patency results of endovascular treatment were often
inferior compared to open repair when the aortic bifurcation was involved in the lesion. In
2013 Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) technique was
introduced in an attempt to improve endovascular treatment results by a more anatomical and
physiological reconstruction, with a subsequent better clinical outcome. The early results of
the CERAB configuration are promising with primary, primary-assisted and secondary patency
of, respectively 86.2%/91.1%/97.0% at 1-year, 83.9%/88.7%/97.0% at 2-year and
82.1%/86.8%/97.0% at 3-year FU in a group of 130 patients, including the first in man
results. The vast majority (89.2%) were TASC-II D lesions and the 30-day major complication
rate was 7.7%.
This trial is designed to prospectively collect all data on implanted CERAB configurations,
using the balloon expandable stents from Bentley InnoMed, in a defined group of aorto-iliac
pathology in multiple international sites in order to gain more insight in the outcome of the
technique. Technical success will be the primary endpoint. Other evaluations will include
patency rates, quality of life, the reintervention-rate, 30-day morbidity and target vessel
revascularization up to 5 years after treatment.
A total of 145 patients will be included and followed until 5 years of follow-up. A core lab
will independently analyze the images (CT scan or duplex) which will be made at the following
time points: pre-op, 1 month, 6 months, 1 year and yearly up to 5 years of follow-up.
Additionally, at these time points three questionnaires will be completed by the patients.
These questionnaires are about walking ability (WIQ), and quality of life (EQ-5D and
WHOQoL-BREF).
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