Registry to Monitor Long-Term Safety and Performance of Intervascular Vascular Grafts and Patches Used in Aortic, Peripheral, or Carotid Artery Procedures

What this Trial Is About

This registry study is designed to monitor the long-term safety and performance of several Intervascular Vascular Grafts and Patches, including Intergard Standard, Hemashield, Intergard Silver, and Intergard Synergy. These devices are used for bypass, repair, or replacement of aortic, peripheral, or carotid arteries. The study aims to better understand the expected lifespan of these products and assess the usefulness of their antimicrobial coatings. Participants have previously undergone vascular procedures using these grafts or patches. The study observes patients across three groups based on their treated artery type Peripheral Arterial Disease, Aortic Disease, and Carotid Artery Disease cohorts. Devices with antimicrobial coatings such as silver acetate and triclosan are also evaluated to track infection prevention. Data collection spans an anticipated average of five years following the surgical procedure. Throughout the study, participants medical records are reviewed to assess outcomes such as device patency, freedom from occlusion or reintervention, incidence of major adverse events, infections, technical success, and changes in vascular health indicators. This observational registry does not involve active treatment but collects long-term safety and performance data. The study is expected to continue until December 2026, with participants contributing data over multiple years post-procedure.

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry