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.
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
- 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.
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
- 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
- Not yet recruiting
Marienhospital Lünen
Lünen
Martin Schröder, 02306/772931, schroeder.martin@klinikum-luenen.de
- 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
Netherlands6 sites, 6 recruiting
- 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
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.
- Conditions
- 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.
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
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)
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
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
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
Time to re-vascularization/re-intervention
Time to re-vascularization/re-intervention
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
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.
- First posted7 Apr 2023
- Study start5 Apr 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorto-iliac Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Marc Bosiers, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marc Bosiers, MD, FCRE (Foundation for Cardiovascular Research and Education)
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