Early Feasibility Study to Evaluate the Safety of Photochemical Tissue Passivation (PTP) Treatment of Saphenous Vein Grafts in Participants Undergoing Elective CABG
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Major cardiac adverse events (MACCE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Each subject will have at least 2 saphenous vein grafts. One graft will be randomized to treatment and one graft will be randomized to control. The outcomes assessor will be blinded to which graft has been treated.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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/1.73m
- •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.
结局指标
主要结局
Major cardiac adverse events (MACCE)
时间窗: 30-days
Major adverse cardiac and cerebral events (MACCE) including all-cause mortality, MI, stroke, and revascularization
次要结局
- Major cardiac adverse events (MACCE)(1-year)