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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aorto-iliac Occlusive Disease
• Intervention / Treatment: Device: endovascular intervention

• Study Type: Observational
• Enrollment (Estimated): 109

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Sankt Gertrauden-Krankenhaus
    • Contact: Ioannis Passaloglou, Dr. med. univ.; Phone Number: 030 8272-2891; Email: Ioannis.Passaloglou@sankt-gertrauden.de
  • Frankfurt, Germany
    • Recruiting
    • Universitatsklinikum Frankfurt
    • Contact: Kyriakos Oikonomou; Phone Number: 06963014136; Email: Kyriakos.oikonomou@unimedizin-ffm.de
  • Göttingen, Germany
    • Recruiting
    • University Medical Center Goettingen
    • Contact: Florian Elger; Phone Number: '49 551 39 68004; Email: florian.elger@med.uni-goettingen.de
  • Heidelberg, Germany
    • Recruiting
    • Universitätsklinikum Heidelberg
    • Contact: Dittmar Böckler; Phone Number: +496221566249; Email: dittmar.boeckler@med.uni-heidelberg.de
  • Lünen, Germany
    • Not yet recruiting
    • Marienhospital Lünen
    • Contact: Martin Schröder; Phone Number: 02306/772931; Email: schroeder.martin@klinikum-luenen.de
  • Münster, Germany
    • Recruiting
    • St. Franziskus-Hospital GmbH
    • Contact: Martin Austermann; Phone Number: +4994136992220; Email: martin.austermann@sfh-muenster.de
  • Regensburg, Germany
    • Recruiting
    • Krankenhaus Barmherzige Brüder Regensburg
    • Contact: Markus Steinbauer; Phone Number: +4994136992220; Email: markus.steinbauer@barmherzige-regensburg.de
  • Regensburg, Germany
    • Recruiting
    • Uniklinikum Regensburg
    • Contact: Karin Pfister; Phone Number: 09419446911; Email: karin.pfister@klinik.uni-regensburg.de
  • Stuttgart, Germany
    • Recruiting
    • Klinikum Der Landeshauptstadt Stuttgart gKAöR
    • Contact: Philipp Geisbüsch; Phone Number: +4971127854539; Email: p.geisbuesch@klinikum-stuttgart.de
• Netherlands
  • Alkmaar, Netherlands
    • Recruiting
    • Noordwest Ziekenhuisgroep Alkmaar
    • Contact: Ünlü Cagdas; Phone Number: +31 624612372; Email: Cagdas.Unlu@nwz.nl
  • Arnhem, Netherlands
    • Recruiting
    • Ziekenhuis Rijnstate Arnhem
    • Contact: Michel Reijnen; Phone Number: +31 88 005 7282; Email: mreijnen@rijnstate.nl
  • Den Haag, Netherlands
    • Recruiting
    • HMC (Haaglanden Medisch Centrum)
    • Contact: Ayoub Charenhibili; Phone Number: +31 088 979 6035; Email: a.charehbili@haaglandenmc.nl
  • Groningen, Netherlands
    • Recruiting
    • Martini Ziekenhuis
    • Contact: Niels Vos; Phone Number: +31 505247988; Email: n.vos2@mzh.nl
  • Groningen, Netherlands
    • Recruiting
    • UMCG Groningen
    • Contact: Jean de Vries; Phone Number: +31 652724010; Email: j.p.p.m.de.vries@umcg.nl
  • Maastricht, Netherlands
    • Recruiting
    • Maastricht UMC+
    • Contact: Barend Mees; Phone Number: +31 43 387 7478; Email: barend.mees@mumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with aorto-iliac occlusive disease, who have been diagnosed by means of Rutherford Becker Classification between 2 and 5.

Description

General Inclusion criteria

1. Patient has been identified with an chronic aorto-iliac occlusive lesion, with clinical necessity for treatment.
2. The patient has been diagnosed with symptomatic peripheral artery disease, defined by Rutherford Becker Classification score 2 to 5.
3. Patient has a projected life-expectancy of at least 24 months.
4. Patient is ≥18 years old.
5. 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:

1. Patient's anatomy is eligible for CERAB treatment, without the need for chimneys and can be treated with a Ø 12 mm BGA.
2. The aorto-iliac lesion begins at least 1 cm below the patent renal arteries without a need for treatment.
3. 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.
4. The target lesion has angiographic evidence of stenosis >50% or occlusion.
5. Patient's common femoral artery and deep femoral artery are patent.

General Exclusion criteria:

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

Angiographic exclusion criteria

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from clinically-driven target lesion revascularization	Freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as freedom from repeat endovascular revascularization to maintain or re-establish patency within the treated lesion.	at 12 months after procedure
Incidence of Serious Adverse Device Effects	Incidence of Serious Adverse Device Effects (SADE) and procedure related Serious Adverse Events (SAE) at 12 months follow up.	at 12 months after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate after procedure	Technical success rate after procedure defined as successful introduction and deployment of the study devices BeGraft Aortic covered stent Graft System & the BeGraft Peripheral covered stent Graft System (Bentley Innomed, Hechingen, Germany) for CERAB procedures	at procedure
Freedom for conversion to open surgical repair	Freedom for conversion to open surgical repair of the target lesion.	at 30 days post-procedure, 6-, 12-, and 24-months
Patency rate of the target vessel	Patency rate of the target vessel (primary, primary assisted and secondary).	at 30 days post-procedure, 6-, 12-, and 24-months
Time to re-vascularization/re-intervention	Time to re-vascularization/re-intervention	at 30 days post-procedure, 6-, 12-, and 24-months
Patient reported outcomes	Patient reported outcomes at 30 days post-procedure, 6-, 12-, and 24-months compared to pre-procedure	at 30 days post-procedure, 6-, 12-, and 24-months
Clinical success at every follow up visit	Clinical success at every follow up visit, defined as an improvement of Rutherford classification of one class or more compared to the pre-procedure Rutherford classification	at 30 days post-procedure, 6-, 12-, and 24-months
Hemodynamic improvement	Hemodynamic improvement defined as increase in Ankle Brachial Index (ABI) of at least 0.10 compared to baseline ABI (pre-procedure) at 30 days post-procedure, 6-, 12-, and 24-months.	at 30 days post-procedure, 6-, 12-, and 24-months
Safety endpoints	Incidence of Serious Adverse Device Effects (SADE) and procedure related Serious Adverse Events (SAE); 30-day mortality.; Overall survival rate; Incidence of Major Adverse Events	at 30 days post-procedure, 6-, 12-, and 24-months

Collaborators and Investigators

• Sponsor: Marc Bosiers, MD

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: FCRE-200622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No