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

NCT05805111 | Recruiting DMC

• 1 other identifier: FCRE-200622
• Study Type: observational
• Target: 109
• Locations: 2 countries
• Sites: 15

Brief 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.

Conditions

Aorto-iliac Occlusive Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Technical success rate after procedure

  at procedure

• Freedom for conversion to open surgical repair

  at 30 days post-procedure, 6-, 12-, and 24-months

• Patency rate of the target vessel

  at 30 days post-procedure, 6-, 12-, and 24-months

• Time to re-vascularization/re-intervention

  at 30 days post-procedure, 6-, 12-, and 24-months

• Patient reported outcomes

  at 30 days post-procedure, 6-, 12-, and 24-months

Interventions

endovascular intervention DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marc Bosiers, MD: lead

Study Sites (15)

Sankt Gertrauden-Krankenhaus

Berlin, Germany

RECRUITING

Universitätsklinikum Frankfurt

Frankfurt, Germany

RECRUITING

University Medical Center Goettingen

Göttingen, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, Germany

RECRUITING

Marienhospital Lünen

Lünen, Germany

NOT YET RECRUITING

St. Franziskus-Hospital GmbH

Münster, Germany

RECRUITING

Krankenhaus Barmherzige Brüder Regensburg

Regensburg, Germany

RECRUITING

Uniklinikum Regensburg

Regensburg, Germany

RECRUITING

Klinikum der Landeshauptstadt Stuttgart gKAöR

Stuttgart, Germany

RECRUITING

Noordwest Ziekenhuisgroep Alkmaar

Alkmaar, Netherlands

RECRUITING

Ziekenhuis Rijnstate Arnhem

Arnhem, Netherlands

RECRUITING

Martini Ziekenhuis

Groningen, Netherlands

RECRUITING

UMCG Groningen

Groningen, Netherlands

RECRUITING

Maastricht UMC+

Maastricht, Netherlands

RECRUITING

HMC (Haaglanden Medisch Centrum)

The Hague, Netherlands

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 7, 2023
• Study Start: April 5, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (6); DE (9)