The DuraGraft® Registry is a European registry of patients who have undergone CABG and whose vascular grafts have been treated with DuraGraft. All participating sites will be from countries in Europe. The DuraGraft Registry will collect pre-CABG, intraoperative and post-operative data, major post-CABG cardiovascular adverse events, health economic outcomes and patient reported quality of life over a period of 5 years.

Objectives:

(i) To evaluate the Safety and Performance of DuraGraft®

(ii) To characterize the use of DuraGraft and the outcomes of patients whose vascular grafts were treated with DuraGraft in daily clinical routine

(iii) To further characterize the incidence of MACCE outcomes associated with CABG in patients whose vascular grafts were treated with DuraGraft in daily clinical routine

(iv) To compare the use of DuraGraft among hospitals and practices

(v) To obtain patient reported quality of life information

(vi) To obtain important health economics outcomes

Inclusion Criteria:

• Patient undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery with at least one saphenous vein or radial artery grafts
• Patient is ≥18 years of age
• Patient (or a legally authorized representative) is willing and able to provide consent
• DuraGraft is being used for the CABG procedure

Exclusion Criteria:

• Participation in a device study or receiving active drug product in an investigational study within one month prior to enrollment

Patients undergoing isolated CABG procedure or CABG plus aortic or mitral valve surgery

Plan to share data to be determined. A Registry Advisory Committee (RAC) will be formed to provide overall scientific direction for the Registry. A publications sub-committee, composed of a subset of the RAC is planned. This sub-committee will be responsible for overseeing the review and approval of all presentations and all publications related to the DuraGraft Registry.

February 2025

To be determined