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

Not yet recruiting

• Conditions: Aorto-iliac Occlusive Disease

• Registration Number: NCT05805111
• Lead Sponsor: Dr. Sabrina Overhagen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-03-28
• Study First Posted: 2023-04-07
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-06
• Study Start: 2023-07
• Primary Completion: 2026-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 117

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from clinically-driven target lesion revascularization	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.
Incidence of Serious Adverse Device Effects	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 Outcome Measures

Name	Time	Method
Patient reported outcomes	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
Clinical success at every follow up visit	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
Hemodynamic improvement	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.
Freedom for conversion to open surgical repair	at 30 days post-procedure, 6-, 12-, and 24-months	Freedom for conversion to open surgical repair of the target lesion.
Patency rate of the target vessel	at 30 days post-procedure, 6-, 12-, and 24-months	Patency rate of the target vessel (primary, primary assisted and secondary).
Time to re-vascularization/re-intervention	at 30 days post-procedure, 6-, 12-, and 24-months	Time to re-vascularization/re-intervention
Technical success rate after procedure	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
Safety endpoints	at 30 days post-procedure, 6-, 12-, and 24-months	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