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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aorto-iliac Occlusive Disease
• Intervention / Treatment: Device: endovascular intervention

• Study Type: Observational
• Enrollment (Estimated): 117

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

1. Patient has been identified with an 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 and capable to provide written consent to participate to the trial and confirmed to attend the expected follow-up visits.
6. Patient's anatomy is eligible for CERAB treatment, without the need for chimneys and can be treated with a Ø 12 mm BGA.
7. The aorto-iliac lesion begins at least 1 cm below the patent renal arteries without a need for treatment.
8. A maximum of 3 BeGraft Peripheral (Ø 7 or 8 mm) per limb in the external iliac artery can be used. In case a Ø 7 mm is used to extent, the distal ends must be flared to Ø 8 mm to ensure proper flow.
9. The target lesion has angiographic evidence of stenosis >50% or occlusion of the limb.
10. Patient's common femoral artery and deep femoral artery are patent.

Exclusion Criteria:

1. Patient is currently participating in another investigational drug or device trial that has not completed the entire follow up period.
2. Patient has planned any surgical intervention/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 with acute aortic or iliac occlusive disease.
6. Patient has an acute systemic infection at time of screening or in period of 30 days prior to screening.
7. Patient has fresh thrombus at time of screening or in period of 14 days prior to screening.
8. Patient has a CERAB procedure that is staged.
9. Female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding.
10. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated.
11. Patients with known hypersensitivity to the stent material (L605) and/or PTFE.
12. An aneurysm in the abdominal aortic and iliac segments where CERAB will be placed is present.
13. Patient has access vessel that is too tortuous, narrow or any other reason that would lead to failure of introducing and advancing an introducer sheath.
14. Patient has or had aortic coarctation.
15. Patient had aortic injury/trauma related interventions previously.
16. Patient had suprarenal/visceral segment reconstructions previously.
17. A relevant accessory renal artery (>3 mm) in the infrarenal aorta is present, that might be occluded during the procedure.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at procedure
Freedom for conversion to open surgical repair	Freedom for conversion to open surgical repair of the target lesion.	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).	at 30 days post-procedure, 6-, 12-, and 24-months
Time to re-vascularization/re-intervention	Time to re-vascularization/re-intervention	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	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	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.	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	at 30 days post-procedure, 6-, 12-, and 24-months

Collaborators and Investigators

• Sponsor: Dr. Sabrina Overhagen

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FCRE-200622

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No