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Aorto-iliac Occlusive DiseaseNCT05805111

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

An observational study of Aorto-iliac Occlusive Disease, run by Marc Bosiers, MD at 15 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Aorto-iliac Occlusive Disease
What is being tested?
endovascular intervention
Type of treatment
Medical device
How many people
109 participants
Where
15 sitesin 2 countries
Study dates
5 Apr 2024to Jul 2027
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

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.

Trial locations and contacts

15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

15 sites in 2 countries

Germany9 sites, 9 recruiting
  • Sankt Gertrauden-Krankenhaus

    Berlin

    Ioannis Passaloglou, Dr. med. univ., 030 8272-2891, Ioannis.Passaloglou@sankt-gertrauden.de

    Recruiting
  • Universitätsklinikum Frankfurt

    Frankfurt

    Kyriakos Oikonomou, 06963014136, Kyriakos.oikonomou@unimedizin-ffm.de

    Recruiting
  • University Medical Center Goettingen

    Göttingen

    Florian Elger, '49 551 39 68004, florian.elger@med.uni-goettingen.de

    Recruiting
  • Universitätsklinikum Heidelberg

    Heidelberg

    Dittmar Böckler, +496221566249, dittmar.boeckler@med.uni-heidelberg.de

    Recruiting
  • Marienhospital Lünen

    Lünen

    Martin Schröder, 02306/772931, schroeder.martin@klinikum-luenen.de

    Not yet recruiting
  • St. Franziskus-Hospital GmbH

    Münster

    Martin Austermann, +4994136992220, martin.austermann@sfh-muenster.de

    Recruiting
  • Krankenhaus Barmherzige Brüder Regensburg

    Regensburg

    Markus Steinbauer, +4994136992220, markus.steinbauer@barmherzige-regensburg.de

    Recruiting
  • Uniklinikum Regensburg

    Regensburg

    Karin Pfister, 09419446911, karin.pfister@klinik.uni-regensburg.de

    Recruiting
  • Klinikum der Landeshauptstadt Stuttgart gKAöR

    Stuttgart

    Philipp Geisbüsch, +4971127854539, p.geisbuesch@klinikum-stuttgart.de

    Recruiting

Other trials in Germany

Netherlands6 sites, 6 recruiting
  • Noordwest Ziekenhuisgroep Alkmaar

    Alkmaar

    Ünlü Cagdas, +31 624612372, Cagdas.Unlu@nwz.nl

    Recruiting
  • Ziekenhuis Rijnstate Arnhem

    Arnhem

    Michel Reijnen, +31 88 005 7282, mreijnen@rijnstate.nl

    Recruiting
  • Martini Ziekenhuis

    Groningen

    Niels Vos, +31 505247988, n.vos2@mzh.nl

    Recruiting
  • UMCG Groningen

    Groningen

    Jean de Vries, +31 652724010, j.p.p.m.de.vries@umcg.nl

    Recruiting
  • Maastricht UMC+

    Maastricht

    Barend Mees, +31 43 387 7478, barend.mees@mumc.nl

    Recruiting
  • HMC (Haaglanden Medisch Centrum)

    The Hague

    Ayoub Charenhibili, +31 088 979 6035, a.charehbili@haaglandenmc.nl

    Recruiting

Other trials in Netherlands

About this study

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

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.

Being tested
endovascular intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endovascular interventionDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at 12 months after procedure

  2. 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.

    Measured: at 12 months after procedure

Secondary outcomes (8)
  1. 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

    Measured: at procedure

  2. Freedom for conversion to open surgical repair

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

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

  3. Patency rate of the target vessel

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

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

  4. Time to re-vascularization/re-intervention

    Time to re-vascularization/re-intervention

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

  5. Patient reported outcomes

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

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

  6. 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

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

  7. 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.

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

  8. Safety endpoints

    1. Incidence of Serious Adverse Device Effects (SADE) and procedure related Serious Adverse Events (SAE)
    2. 30-day mortality.
    3. Overall survival rate
    4. Incidence of Major Adverse Events

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2023
  2. Study start5 Apr 2024
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
109 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05805111
Sponsor's protocol ID
FCRE-200622
Status last verified
Jun 2025
First submitted
28 Mar 2023
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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