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

Recruiting

• Conditions: Aorto-iliac Occlusive Disease

• Registration Number: NCT05805111
• Lead Sponsor: Marc Bosiers, MD

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
• Study Start: 2024-04-05
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-15
• Primary Completion: 2026-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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

Trial Locations

Locations (15)

Sankt Gertrauden-Krankenhaus; 🇩🇪 Berlin, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

University Medical Center Goettingen; 🇩🇪 Göttingen, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Marienhospital Lünen; 🇩🇪 Lünen, Germany

St. Franziskus-Hospital GmbH; 🇩🇪 Münster, Germany

Krankenhaus Barmherzige Brüder Regensburg; 🇩🇪 Regensburg, Germany

Uniklinikum Regensburg; 🇩🇪 Regensburg, Germany

Klinikum der Landeshauptstadt Stuttgart gKAöR; 🇩🇪 Stuttgart, Germany

Noordwest Ziekenhuisgroep Alkmaar; 🇳🇱 Alkmaar, Netherlands

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