Coronary Artery Disease Clinical Trial
Official title:
Early Feasibility Study to Evaluate the Safety and Effectiveness of Photochemical Tissue Passivation (PTP) Treatment of Saphenous Vein Grafts in Participants Undergoing Elective CABG
Early feasibility study of the DurVena Photochemical Tissue Passivation (PTP) device for treatment of saphenous vein grafts in participants undergoing elective coronary artery bypass graft (CABG) surgery. Study to be conducted outside the U.S.
The Photochemical Tissue Passivation (PTP) treatment of a saphenous vein graft (SVG) is indicated for the reduction of intimal hyperplasia and graft failure rate in SVGs after coronary bypass graft (CABG) surgery. The primary study objective, in this early feasibility study outside the US, is to characterize the safety profile of the PTP device and secondarily to gain a preliminary understanding of the efficacy of PTP-treated SVGs when used during CABG surgery in participants with multivessel atherosclerotic coronary artery disease (CAD). This is a prospective, randomized, within-subject controlled early feasibility study. Up to 15 participants with multivessel CAD will be recruited for this study and followed for a minimum of 1 year. ;
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