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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
4
Treatment of a saphenous vein graft with the DurVena Photochemical Tissue Passivation device.
Republican Scientific Center of Emergency Medical Care
Tashkent, Uzbekistan
Major cardiac adverse events (MACCE)
Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization
Time frame: 30-days
Major cardiac adverse events (MACCE)
Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization
Time frame: 6-months
Major cardiac adverse events (MACCE)
Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization
Time frame: 1-year
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