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NCT Number: NCT05805111

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sankt Gertrauden-Krankenhaus, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Freedom from clinically-driven target lesion revascularization

    Time frame: at 12 months after procedure

    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.

  2. Incidence of Serious Adverse Device Effects

    Time frame: at 12 months after procedure

    Incidence of Serious Adverse Device Effects (SADE) and procedure related Serious Adverse Events (SAE) at 12 months follow up.

Secondary outcomes

  1. Technical success rate after procedure

    Time frame: at 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

  2. Freedom for conversion to open surgical repair

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

    Freedom for conversion to open surgical repair of the target lesion.

  3. Patency rate of the target vessel

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

    Patency rate of the target vessel (primary, primary assisted and secondary).

  4. Time to re-vascularization/re-intervention

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

    Time to re-vascularization/re-intervention

  5. Patient reported outcomes

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

    Patient reported outcomes at 30 days post-procedure, 6-, 12-, and 24-months compared to pre-procedure

  6. Clinical success at every follow up visit

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

    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

  7. Hemodynamic improvement

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

    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.

  8. Safety endpoints

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

    • 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

Sponsors and collaborators

Lead sponsor

Marc Bosiers, MD

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 7, 2023
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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