Prospective, Non-Randomised Clinical Trial to Investigate the BeGraft Aortic Stent Graft System a… (NCT05805111) | Clinical Trial Compass
RecruitingNot Applicable
Prospective, Non-Randomised Clinical Trial to Investigate the BeGraft Aortic Stent Graft System and the BeGraft Peripheral Stent Graft System Treating Aortic-iliac Occlusive Disease
Germany109 participantsStarted 2024-04-05
Plain-language summary
This is a prospective, multi-center, investigational study to evaluate safety and performance of the BeGraft Aortic balloon expandable covered Stent Graft System and the BeGraft Peripheral balloon expandable covered stent Graft System (Bentley InnoMed GmbH, Hechingen, Germany) implanted as covered stents in CERAB procedures (Covered Endovascular Reconstruction of Aortic Bifurcation) for extensive aorto-iliac occlusive disease.
The objective of this clinical investigation is to evaluate the safety and performance of the BeGraft Aortic covered stent Graft System \& the BeGraft Peripheral covered stent Graft System (Bentley Innomed, Hechingen, Germany) in CERAB configuration (Covered Endovascular Reconstruction of Aortic Bifurcation) for Aorto-iliac Occlusive Disease.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Patient has been identified with an chronic aorto-iliac occlusive lesion, with clinical necessity for treatment.
✓. The patient has been diagnosed with symptomatic peripheral artery disease, defined by Rutherford Becker Classification score 2 to 5.
✓. Patient has a projected life-expectancy of at least 24 months.
✓. Patient is ≥18 years old.
✓. Patient is willing/capable and provides written consent to participate to the trial and confirmed to attend the expected follow-up visits.
✓. Patient's anatomy is eligible for CERAB treatment, without the need for chimneys and can be treated with a Ø 12 mm BGA.
✓. The aorto-iliac lesion begins at least 1 cm below the patent renal arteries without a need for treatment.
✓. A maximum of 3 BeGraft Peripheral (Ø 7 or 8 mm) per limb in the iliac artery can be used. In case a Ø 7 mm is used to extend, the overlapping end must be post-dilated to ensure proper flow.
Exclusion criteria
What they're measuring
1
Freedom from clinically-driven target lesion revascularization