Comparison of Primary Patency Between GORE PROPATEN Vascular Graft and Disadvantaged Autologous Vein Graft For Below-Knee Arterial Bypass (PRODIGY Study)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 34
- 主要终点
- Number of Patients With Primary Patency at 12 Months Post-procedure
研究概览
简要总结
The primary patency of the GORE PROPATEN Vascular Graft is equivalent to or better than disadvantaged autologous vein graft in an infragenicular peripheral bypass application at 12 months.
详细描述
Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow. A disadvantaged autologous vein is defined as meeting at least one of the two following criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator; (2) Usable ipsilateral or contralateral autologous greater saphenous vein that meets any of the following criteria: (a) Diameter of less than or equal to 3.0 mm; (b) Inadequate length requiring splicing; (c) Poor quality vein that is either sclerotic or phlebitic.
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
- None
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
- •Patient requires below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease.
- •Patient meets the disadvantaged autologous vein criteria described in Section 4.
- •Patient has a post-operative life expectancy greater than one year.
- •Patient is at least 21 years of age.
- •Patient is able to comply with all study requirements and be available for follow-up visits at 1, 6, 12, 24 and 36-months post-procedure.
- •Patient is willing and able to provide written, informed consent.
排除标准
- •Patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin.
- •Patient requires an infragenicular bypass for reasons other than peripheral arterial occlusive disease.
- •Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts.
- •Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure. However, inflow procedures that facilitate the bypass are permitted, as long as they are not performed at the same sitting as the bypass procedure.
- •Patient has been previously randomized for this study.
- •Patient has active infection in the region of graft placement.
结局指标
主要结局
Number of Patients With Primary Patency at 12 Months Post-procedure
时间窗: 12 months
Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.
Major Adverse Event Occurrences Through One Month Post-procedure
时间窗: one month post-index procedure
The number of Major Adverse Event occurrences through one month post-procedure. A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. This outcome measure presents the number of Major Adverse Event occurrences (i.e. - one patient could have multiple occurrences), and differs from the Serious Adverse Events reporting measure, which presents the number of patients that have been affected by a Serious Adverse Event.
次要结局
- Number of Patients With Primary Patency at One Month Post-procedure(One month)
- Number of Patients With Primary Patency at 6 Months Post-procedure(6 months)
- Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure(12 months)
- Number of Patients With Assisted Primary Patency at One Month Post-procedure(One month)
- Number of Patients With Assisted Primary Patency at 6 Months Post-procedure(6 months)
- Number of Patients With Assisted Primary Patency at 12 Months Post-procedure(12 months)
- Number of Patients With Secondary Patency at One Month(One month)
- Number of Patients With Secondary Patency at 6 Months(6 months)
- Number of Patients With Secondary Patency at 12 Months(12 months)
- Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure(One month)
- Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure(6 months)
- Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure(12 months)
- Patients Experiencing Major Adverse Events Through 6 Months Post-procedure(6 months)
- Patients Experiencing Major Adverse Events Through 12 Months Post-procedure(12 months)
- Number of Patients Surviving at One Month(One month)
- Number of Patients Surviving at 6 Months(6 months)
- Number of Patients Surviving at 12 Months(12 months)
- Number of Patients With Wound/Graft Infection Through One Month Post-procedure(One month)
- Number of Patients With Wound/Graft Infection Through 6 Months(6 months)
- Number of Patients With Wound/Graft Infection Through 12 Months(12 months)
- Number of Patients With Delayed Wound Healing Through One Month Post-procedure(One month)
- Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure(6 months)
- Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure(One month)