Post-Market Clinical Follow-up Registry to Evaluate Safety and Performance of Intervascular Vascular Grafts and Patches for Bypass, Replacement, or Repair of Aortic, Peripheral, or Carotid Arteries

What this Trial Is About

This research aims to assess the long-term safety and performance of Intervascular Vascular Grafts and Patches, including Intergard Standard, Hemashield, Intergard Silver, and Intergard Synergy, used for bypass, repair, or replacement of aortic, peripheral, or carotid arteries. The study focuses on evaluating the product lifetime and the usefulness of antimicrobial coatings on these devices. The registry collects data from patients who have undergone these specific vascular procedures. Participants receive one of the Intervascular vascular grafts or patches, which vary by type and coating. The devices include collagen-coated grafts designed to reduce bleeding and antimicrobial-coated grafts intended to prevent infections. The study includes different patient groups based on the affected artery: Peripheral Arterial Disease, Aortic Disease, and Carotid Artery Disease cohorts. Data collection extends from the time of surgery through an anticipated average follow-up of five years. During the study, researchers collect data from medical records to monitor device patency, incidence of adverse events such as limb events or infections, and technical success rates. Follow-up includes tracking changes in clinical measures like the Rutherford Category and Ankle-Brachial Index for peripheral artery patients. The registry observes participants over at least three years and up to approximately five years to understand long-term outcomes and device performance in real-world use.

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