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

Official title

CERAB - 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 With CERAB

Overview

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.

Interventions

• Device endovascular intervention
  Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) is a new, minimally invasive technique, for treating extensive and/or recurrent aorto-iliac occlusive disease. The technique rebuilds the diseased aortic bifurcation and iliac arteries through the use of stent-grafts introduced through the groin or arm arteries.

Primary outcome measures

• Freedom from clinically-driven target lesion revascularization [Time frame: at 12 months after procedure]
• Incidence of Serious Adverse Device Effects [Time frame: at 12 months after procedure]

Secondary outcome measures (8)

• Technical success rate after procedure [Time frame: at procedure]
• Freedom for conversion to open surgical repair [Time frame: at 30 days post-procedure, 6-, 12-, and 24-months]
• Patency rate of the target vessel [Time frame: at 30 days post-procedure, 6-, 12-, and 24-months]
• Time to re-vascularization/re-intervention [Time frame: at 30 days post-procedure, 6-, 12-, and 24-months]
• Patient reported outcomes [Time frame: at 30 days post-procedure, 6-, 12-, and 24-months]
• Clinical success at every follow up visit [Time frame: at 30 days post-procedure, 6-, 12-, and 24-months]
• Hemodynamic improvement [Time frame: at 30 days post-procedure, 6-, 12-, and 24-months]
• Safety endpoints [Time frame: at 30 days post-procedure, 6-, 12-, and 24-months]

Eligibility criteria

General 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.

Angiographic inclusion criteria:

• 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.
• The target lesion has angiographic evidence of stenosis >50% or occlusion.
• Patient's common femoral artery and deep femoral artery are patent.

General Exclusion criteria:

• Patient is currently participating in another interventional drug trial or device trial that has not completed the entire follow up period.
• Patient has planned any surgical intervention/procedure, that is not related to the study procedure, within 30 days after the study procedure.
• Patient had a Myocardial infarction or stroke within a period of 3 months prior to the study procedure.
• Patient had surgery (e.g. bypass surgery or stenting) in target vessels previously.
• Patient has an acute severe systemic infection at time of screening or in period of 30 days prior to screening.
• Patient has fresh thrombus at time of screening or in period of 14 days prior to screening.
• Patient has a CERAB procedure that is staged.
• Female patient with childbearing potential not taking adequate contraceptives.
• Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated.
• Patients with known hypersensitivity to the stent material (L605) and/or PTFE.
• Patients who are placed in an institution due to an institutional or court order.
• An aneurysm in the abdominal aortic and iliac segments where CERAB will be placed is present.
• Patient has or had aortic coarctation.
• Patient had aortic injury/trauma related interventions previously.
• Patient had suprarenal/visceral segment reconstructions previously.

Angiographic exclusion criteria

• Failure of recanalization
• A relevant accessory renal artery (>3 mm) in the infrarenal aorta is present, that might be occluded during the procedure.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Germany · 9 centers

• Sankt Gertrauden-Krankenhaus — Berlin
• Universitätsklinikum Frankfurt — Frankfurt
• University Medical Center Goettingen — Göttingen
• Universitätsklinikum Heidelberg — Heidelberg
• Marienhospital Lünen — Lünen
• St. Franziskus-Hospital GmbH — Münster
• Krankenhaus Barmherzige Brüder Regensburg — Regensburg
• Uniklinikum Regensburg — Regensburg
• … and 1 more center

Netherlands · 6 centers

• Noordwest Ziekenhuisgroep Alkmaar — Alkmaar
• Ziekenhuis Rijnstate Arnhem — Arnhem
• Martini Ziekenhuis — Groningen
• UMCG Groningen — Groningen
• Maastricht UMC+ — Maastricht
• HMC (Haaglanden Medisch Centrum) — The Hague

Identifiers

NCT: NCT05805111 · FCRE-200622

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗