Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aorto-iliac Occlusive Disease
Lead sponsor: FCRE (Foundation for Cardiovascular Research and Education)
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from clinically-driven target lesion revascularization
timeFrame: at 12 months after procedure
measure: Incidence of Serious Adverse Device Effects
timeFrame: at 12 months after procedure
Secondary outcomes:
measure: Technical success rate after procedure
timeFrame: at procedure
measure: Freedom for conversion to open surgical repair
timeFrame: at 30 days post-procedure, 6-, 12-, and 24-months
measure: Patency rate of the target vessel
timeFrame: at 30 days post-procedure, 6-, 12-, and 24-months
measure: Time to re-vascularization/re-intervention
timeFrame: at 30 days post-procedure, 6-, 12-, and 24-months
measure: Patient reported outcomes
timeFrame: at 30 days post-procedure, 6-, 12-, and 24-months
measure: Clinical success at every follow up visit
timeFrame: at 30 days post-procedure, 6-, 12-, and 24-months
measure: Hemodynamic improvement
timeFrame: at 30 days post-procedure, 6-, 12-, and 24-months
measure: Safety endpoints
timeFrame: at 30 days post-procedure, 6-, 12-, and 24-months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Sankt Gertrauden-Krankenhaus
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Göttingen
country: Germany
facility: University Medical Center Goettingen
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Lünen
country: Germany
facility: Marienhospital Lünen
city: Münster
country: Germany
facility: St. Franziskus-Hospital GmbH
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder Regensburg
city: Regensburg
country: Germany
facility: Uniklinikum Regensburg
city: Stuttgart
country: Germany
facility: Klinikum der Landeshauptstadt Stuttgart gKAöR
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep Alkmaar
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate Arnhem
city: Den Haag
country: Netherlands
facility: HMC (Haaglanden Medisch Centrum)
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Groningen
country: Netherlands
facility: UMCG Groningen
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
Study officials:
References: