Intervascular PMCF Registry

Objectif(s) de la recherche et intérêt pour la santé publique

Finalité de l'étude

Objectifs poursuivis

Domaines médicaux investigués

Bénéfices attendus

This multi-center, retrospective review focuses on participants who have received Intervascular vascular grafts or patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy) for bypass, repair, or replacement of aortic, peripheral, or carotid arteries. The study holds significant public health relevance by providing insights into the long-term safety, effectiveness, and performance of these devices. By analyzing historical patient data, it enables the identification of long-term complications and adverse events, supporting the development of safer treatment protocols and improved infection control strategies. This is particularly important for reducing post-operative risks and enhancing patient outcomes.

A key aspect of the study is evaluating the real-world performance of antimicrobial coatings, such as silver, which contributes to infection prevention which can support lowering healthcare-associated infection rates. The registry results will inform evidence-based clinical practices and support regulatory oversight, ultimately improving the safety of vascular medical devices at the population level. Additionally, by expanding medical knowledge through large-scale data analysis, this study may support ongoing advancements in healthcare practices and medical device innovation. This not only enhances individual patient care but also contributes to strengthening healthcare systems and improving outcomes for future generations.

The primary objective of this registry is to evaluate the long-term safety and performance of the Intervascular Vascular Grafts and Patches in their use for bypass, repair, or replacement of aortic, peripheral, or carotid arteries. It aims to further define the expected product lifetime and collect data on the usefulness of the antimicrobial coatings.

The study population includes patients with aneurysmal and occlusive disease treated with these Intervascular devices. Up to 400 adult participants will be enrolled in each cohort—peripheral artery disease (PAD), aortic disease, and carotid artery disease—totaling up to 1,200 adult participants.

The methodology is based on a retrospective review of existing medical records across multiple centers, allowing comprehensive long-term evaluation without the need for prospective patient enrollment. This approach facilitates a robust assessment of device performance and safety over time while providing valuable real-world evidence to guide clinical and regulatory decision-making.