A multicenter, non-interventional study investigating post-EVAR aneurysm sac dynamics through longitudinal biobanking.
Status: 🟢 Phase 1 – Ongoing
Coordinating center: Amsterdam UMC, The Netherlands
Study Overview
Bio-Advance is a multicenter, non-interventional clinical research study designed to improve understanding of aneurysm sac behavior following endovascular aortic repair (EVAR). Despite successful implantation of endografts, post-EVAR aneurysm sac dynamics vary considerably between patients and remain poorly understood.
Bio-Advance aims to address this knowledge gap by establishing a high-quality biobank of longitudinal blood samples, imaging data, and clinical parameters from patients treated with EVAR across multiple international centers.
Trial snapshot
Study Type
Multi Center, non-interventional, prospective collection of plasma and peripheral mononuclear cell samples together with CT-images, clinical parameters and lab values.
Population
Post-EVAR abdominal aortic aneurysm patients treated and implanted with Medtronic Endurant TM II/IIs stent graft system or the Gore Excluder AAA Device Family systems.
Devices included in study
Medtronic Endurantâ„¢ II / IIs Stent Graft System and Gore Excluder AAA Device Family
Sample size and study design
Collection of 300 samples, imaging and clinical parameters in 100 patients. Patient inclusion will occur within 1 year, including collection of 100 pre-operative samples. 1 month and 1 year Post operative samples will be collected thereafter to reach 300 samples, imaging and parameters.
Scientific Rationale
Endovascular aortic repair (EVAR) is a widely used treatment for abdominal aortic aneurysms. While many patients demonstrate favorable outcomes with aneurysm sac shrinkage, others experience stable or progressive sac enlargement despite technically successful procedures.
Post-EVAR aneurysm sac behavior is closely associated with long-term outcomes and the need for reintervention. However, the biological mechanisms underlying sac regression or expansion remain poorly understood, and no validated biomarkers currently exist to predict post-EVAR sac dynamics.
Bio-Advance seeks to enable future discovery of biological and molecular parameters associated with post-EVAR aneurysm sac behavior by establishing a well-characterized, longitudinal biobank of biological samples linked to imaging and clinical data.
Participation
All sites are invited to participate in a way that will fit your situation at site:
- You already have a biobank and are able to collect samples:
Please move ahead to collect samples, imaging and clinical parameters. We will facilitate with an MDTA. - You do not have a biobank at site:
We invite you to participate in our current biobank, using our PIF and ICF. Only local approval would be required. We will also facilitate with an MDTA. - Full submission for the study is needed:
Please use our current BIO-ADVANCE Protocol and PIF/ICF and let us know where we can facilitate!
Ethics
Bio-Advance is a non-interventional clinical research study conducted in accordance with applicable ethical and regulatory requirements. Ethical approval is obtained at each participating site, and all patients provide written informed consent prior to participation.
Biological samples are collected during routine clinical procedures and do not exceed standard safety limits.