Polytetrafluoroethylen (PTFE) Vascular Prostheses With Heparin Bonded Luminal Surfaces vs Crude ePTFE in the Treatment of Critical Limb Ischemia Lesions in the Absence of a Suitable Autologous Vein
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 42
- 主要终点
- Primary patency at 1 year:
研究概览
简要总结
Open repair could be recommended in a first line of treatment to revascularize critical limb ischemia patients or performed in a second line of treatment in case of failure of endovascular repair. A good quality vein is one of the main factors that influence the clinical success of open revascularization for below-knee popliteal. In the absence of an suitable autologous vein, prosthesis such as polytetrafluoroethylen (PTFE) graft could be an option but demonstrated worse clinical and morphological results compared to autologous greater saphenous vein. Consequently, there is still a room for improvement in CLI patients in the absence of an suitable autologous vein in whom endovascular repair failed.
Recently, PTFE with heparin-bound to the luminal surface (Hb-PTFE) significantly reduced the overall risk of primary graft failure by 37%, in particular, risk reduction was 50% in femoropopliteal bypass cases in cases with critical ischemia (58% Primary patency for crude ePTFE versus 80% primary patency for PROPATEN at 1 year follow-up) (Lindholt, et. al. 2011).
Additionally, a weighted average from the literature suggests a 76% primary patency for below knee bypasses performed with PROPATEN at one year follow-up, whereas a published meta-analysis suggests a 59% primary patency for below knee crude ePTFE at one year follow-up. At two year follow-up using the same approach, the average primary patency for PROPATEN was 67% versus 43% for standard ePTFE.
The aim of this study is to assess PTFE with heparin-bound to the luminal surface as an alternative to crude PTFE in absence of good venous conduit in patients with CLI.
详细描述
Patient inclusion in this study will be proposed 60 to 1-days period preceding the surgical procedure. The patient will be randomized in the crude PTFE or in the Propaten groups. Regarding the intervention, the technique used during the therapeutic procedure shall be left to the operator's discretion, except the type of the graft. Demographic, intraoperative and postoperative data will be collected prospectively. Patient will be assessed and followed up according a current care. The cost difference between both groups will be identified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥18 years
- •Patient presented critical limb ischemia (Rutherford classification: 4-6)
- •Indication of below the knee bypass with an artificial graft
- •Absence of an suitable autologous vein
- •Patient is affiliated to the Social Security or equivalent system
- •Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to any study related procedure
- •Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site
排除标准
- •No atheromatous disease
- •Female of child bearing potential
- •Patient has a history of coagulopathy or will refuse blood transfusions
- •Patient is receiving or scheduled to receive anticancer therapy for malignancy within 1 year prior to or after the procedure
- •Severe concomitant disease with life expectation < one year
- •Known allergy to heparin
- •Indication for ipsilateral major amputation
- •Patient is not able to give informed consent
- •Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints Note: Trials requiring extended follow-up for products that were investigational, but have become commercially suitable since then, are not considered investigational trials
- •In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
结局指标
主要结局
Primary patency at 1 year:
时间窗: 1 year
It was defined as a patent graft without any intervention to open up or prevent a graft occlusion. Demonstrably patent graft should be by a duplex ultrasound color-flow scan.
次要结局
- Perioperative complications(2 years)
- Technical success defined as a patent bypass without stenosis of the proximal and the distal anastomoses.(2 years)
- Death(1, 12 and 24 months post procedure)
- Secondary patency(1, 12 and 24 months post procedure)
- Ankle brachial index(1, 6, 12 and 24 months post procedure)
- Quality of life at inclusion, .(1, 3, 6, 9, 12, 15, 18 and 24 months)
- Secondary sustained clinical improvement(1, 12 and 24 months post procedure)
- MALE (Major Adverse Limb Event)-free survival rates in subjects with CLI randomized to Propaten vs. crude ePTFE.(1, 6, 12 and 24 months)
- Limb salvage defined as freedom from above-ankle amputation of the index limb(1, 12 and 24 months post procedure)
- Assisted patency(1, 12 and 24 months post procedure)
- Primary sustained clinical improvement(1, 12 and 24 months post procedure)
- Major adverse cardiovascular events(1, 12 and 24 months post procedure)
- cost-effectiveness analysis (CEA)(2 years)
- Primary patency(1 and 24 months post procedure)
- Cost utility analysis (CUA)(2 years)