DuraGraft European Multi-Center Registry

To Assess Outcomes in Patients Undergoing Coronary Artery Bypass Graft Surgery

ClinicalTrials.gov Identifier: NCT02922088

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 are 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.

 

Registry Oversight and Governance

Oversight of the Registry and its governance is through the “Registry Advisory Committee” (RAC) comprised of Lead PIs from each country. The Register charter outlines the roles and responsibilities of all participants, the in-country PI and the Chief Investigator.

 

The RAC plays an important role as an additional oversight group and assists the sponsor in conducting the trial, ensuring that it will produce valid and credible results. The Registry is being conducted in multiple countries in EU and elsewhere and will ultimately consist of over 40+ Centers. Each Center has a PI responsible for the Registry at that Center, and one of the PIs in each Country is elected to represent the country in the RAC.

For More Information on the DuraGraft Registry at ClinicalTrials.gov, Click Here

STEPS Study DuraGraft Prospective Study

A Study to Evaluate the Use of SOMVC001 Vascular Conduit Preservation Solution in Patients Undergoing CABG

ClinicalTrials.gov Identifier: NCT02272582, NCT02774824 

Saphenous vein (SV) harvesting was performed using an open or endoscopic vein harvesting technique. Once harvested, the SV was divided into two segments and these vein segments were randomly assigned to be immersed in one of two blinded solutions: SOMVC001 (DuraGraft) or heparin dosed saline, for use within the same patient. The SVG segment were grafted to the randomly assigned target coronary regions. Imaging, using 64-slice or better MDCT, was completed at 4-6 weeks, 3 months, and 12 months post-surgical (CABG) procedure.

 

For More Information on the DuraGraft study at ClinicalTrials.gov, Click Here