Photochemical Tissue Passivation Treatment of Saphenous Vein Grafts in CABG

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Feasibility Study to Evaluate the Safety and Effectiveness of Photochemical Tissue Passivation (PTP) Treatment of Saphenous Vein Grafts in Participants Undergoing Elective CABG

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: DurVena Photochemical Tissue Passivation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation. Age 21 years or older. Planned and scheduled on-pump, arrested heart CABG. Two or more vein grafts to native vessels having at least 75% stenosis and comparable runoff. IMA graft indicated for the LAD. Appropriately sized and accessible target coronary arteries, with a minimum diameter of 2 mm and adequate vascular bed (without significant distal stenosis), as assessed by pre-operative cardiac angiography and verified by diameter gauging intraoperatively. - Exclusion Criteria: Concomitant non-CABG cardiac surgical procedure. Prior cardiac surgery. Emergency CABG surgery (e.g., cardiogenic shock, inotropic pressure support, intraaortic balloon pump, ECMO). Contraindication for on-pump CABG with cardioplegic arrest (e.g., severely calcified aorta). Calcification at the intended anastomotic sites, as assessed upon opening of the chest and before randomization. Platelets < 50,000/mm3 or other evidence of coagulopathy, INR greater than 1.5 in the absence of anticoagulation therapy. Infection (WBC ≥12.5 x 103/ml and or temperature ≥100.5°F/38°C). History of cerebral vascular accident (CVA) or transient ischemic attacks (TIA) within the last 3 months. Unwilling or unable to receive blood transfusion. Inability to undergo treatment with heparin. Participants on dialysis or GFR of <30 ml/min/1.73m2. Primary liver disease with bilirubin, SGOT, or SGPT > 4X upper limit of normal. Prior history of allergic reaction to contrast media with anaphylaxis or severe peripheral edema. Any medical condition that, in the opinion of the investigator, would compromise the safety of the participant or quality of the study data. Pregnancy and nursing or lactating. Current, or past participation in a clinical trial within the past 30 days.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photochemical tissue passivation group<br>Photochemical tissue passivation of a saphenous vein graft | Device: DurVena Photochemical Tissue Passivation<br>* Treatment of a saphenous vein graft with the DurVena Photochemical Tissue Passivation device.<br>|
| No Intervention: Standard of care group<br>Standard of care treatment of a saphenous vein graft | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiac adverse events (MACCE) | Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization | 30-days | 
| SVG patency | Proportion of PTP-treated SVGs with Fitzgibbon I patency score as measured by cardiac computed tomography angiography (CCTA) | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiac adverse events (MACCE) | Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization | 6-months | 
| Major cardiac adverse events (MACCE) | Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization | 1-year | 
| Intimal hyperplasia | Plaque + media area (mm^2) as measured by intravenous ultrasound (IVUS) | 1-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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saphenous vein grafts, CABG surgery