Actively Recruiting
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
Led by Marc Bosiers, MD · Updated on 2025-06-15
109
Participants Needed
15
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has a chronic aorto-iliac occlusive lesion that needs treatment.
- Diagnosed with symptomatic peripheral artery disease with a Rutherford Becker Classification score of 2 to 5.
- Life expectancy of at least 24 months.
- At least 18 years old.
- Willing and able to provide written consent and attend follow-up visits.
- Patient anatomy eligible for CERAB treatment without need for chimneys and can be treated with a 12 mm BeGraft Aortic stent.
- Aorto-iliac lesion starts at least 1 cm below the patent renal arteries without need for treatment.
- No more than 3 BeGraft Peripheral stents (7 or 8 mm) per limb in the iliac artery are used.
- Target lesion shows angiographic evidence of >50% stenosis or occlusion.
- Common femoral artery and deep femoral artery are open and functioning.
You will not qualify if you...
- Currently participating in another interventional drug or device trial that has not completed follow-up.
- Planned any surgical procedure unrelated to the study within 30 days after the study procedure.
- Had a myocardial infarction or stroke within 3 months before the study procedure.
- Had previous surgery such as bypass or stenting in target vessels.
- Have an acute severe systemic infection at screening or within 30 days prior.
- Have fresh thrombus at screening or within 14 days prior.
- Undergoing a staged CERAB procedure.
- Female with childbearing potential not using adequate contraceptives.
- Contraindications to antiplatelet therapy, anticoagulants, or thrombolytic drugs.
- Known allergy to stent material (L605) or PTFE.
- Placed in an institution by institutional or court order.
- Presence of an aneurysm in the abdominal aortic or iliac segments where CERAB will be placed.
- History of aortic coarctation.
- Previous aortic injury or trauma-related interventions.
- Previous suprarenal or visceral segment reconstructions.
- Failure of recanalization.
- Presence of a relevant accessory renal artery (>3 mm) in the infrarenal aorta that may be occluded during the procedure.
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Sankt Gertrauden-Krankenhaus
Berlin, Germany
Actively Recruiting
2
Universitätsklinikum Frankfurt
Frankfurt, Germany
Actively Recruiting
3
University Medical Center Goettingen
Göttingen, Germany
Actively Recruiting
4
Universitätsklinikum Heidelberg
Heidelberg, Germany
Actively Recruiting
5
Marienhospital Lünen
Lünen, Germany
Not Yet Recruiting
6
St. Franziskus-Hospital GmbH
Münster, Germany
Actively Recruiting
7
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Germany
Actively Recruiting
8
Uniklinikum Regensburg
Regensburg, Germany
Actively Recruiting
9
Klinikum der Landeshauptstadt Stuttgart gKAöR
Stuttgart, Germany
Actively Recruiting
10
Noordwest Ziekenhuisgroep Alkmaar
Alkmaar, Netherlands
Actively Recruiting
11
Ziekenhuis Rijnstate Arnhem
Arnhem, Netherlands
Actively Recruiting
12
Martini Ziekenhuis
Groningen, Netherlands
Actively Recruiting
13
UMCG Groningen
Groningen, Netherlands
Actively Recruiting
14
Maastricht UMC+
Maastricht, Netherlands
Actively Recruiting
15
HMC (Haaglanden Medisch Centrum)
The Hague, Netherlands
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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