Comparison of Safety and Primary Patency Between FUSION Vascular Graft With Bioline and EXXCEL Soft ePTFE (FINEST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 48
- 主要终点
- Number of Participants With Primary Patency
研究概览
简要总结
To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline.
详细描述
The study is a prospective, randomized, single-blind, two-arm, parallel group, multi-center study to evaluate the safety and efficacy of FUSION™ Vascular Graft with Bioline (heparin) coating, compared with EXXCEL Soft ePTFE in a peripheral bypass setting, to support a claim of substantial equivalence.
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 (Participant)
盲法说明
This was a single-blind study. The surgeon and study site staff knew which vascular graft each subject received, but the subject did not.
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 required either above-knee or below-knee femoral popliteal bypass;
- •Patient had Category 1, 2, 3 4 or 5 chronic limb ischemia as defined by the Rutherford Categories - chronic limb ischemia severity classification scale.
- •Patient was at least 21 years of age;
- •Patient had postoperative life expectancy of >18 months;
- •Patient was willing and able to have follow-up visits and examinations;
- •Patient would not participate in other clinical trials that would conflict with this protocol
- •Patient was willing and able to provide written, informed consent.
排除标准
- •Patient had a previous history of bypass in the diseased extremity (below the iliacs arteries);
- •Patient had percutaneous transluminal angioplasty or stenting of the target femoral or popliteal artery at the anticipated site of the proximal or distal anastomosis within the previous 30 days;
- •Patient had active infection in the region of graft placement;
- •Patient had an acute arterial occlusion requiring an emergent intervention;
- •Patient needed a cardiac surgical procedure or a different vascular surgical procedure within 30 days of planned lower extremity revascularization. Planned endovascular procedures to address proximal stenotic lesions at the time of the index femoropopliteal bypass did not exclude a patient from the study;
- •Patient required sequential extremity revascularizations or other procedures that require use of additional vascular grafts;
- •Patient had known hypersensitivity or contraindication to aspirin;
- •Patient had known coagulation disorders including hypercoagulability;
- •Patient had previous instance of heparin-induced thrombocytopenia type 2 or has known hypersensitivity to heparin; Patient was currently treated with Coumadin (warfarin) that had not been stopped within 72 hours of the planned procedure
- •Patient had severe chronic renal insufficiency (plasma/serum creatinine > 2.5 mg/dl), is undergoing hemodialysis.
- •Patient had prior renal transplant;
- •Patient had a stroke or myocardial infarction within 6 weeks of the procedure or had evidence of prior massive stroke (Modified Rankin Scale 3 or above);
- •Patient had a myocardial infarction within 6 weeks prior to the procedure or had unstable angina pectoris;
- •Patient had documented acute or suspected systemic infection;
- •Patient was a woman of reproductive potential.
结局指标
主要结局
Number of Participants With Primary Patency
时间窗: 6 months
A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency. Assessed by duplex ultrasound imaging and ankle brachial index (ABI).
The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD)
时间窗: 6 months
The composite endpoint included any of the following: * Major amputation - amputation that resulted in limb shortening (e.g., proximal to, but not including transmetatarsal amputations); * Major graft reintervention - placement of a new bypass graft at the same anatomic site, a jump/interposition graft, graft thrombectomy, graft excision, or graft thrombolysis; * Procedure-related death - any death within 30 days of the index procedure or within 30 days of any remedial procedure performed at the same anatomic site or as a result of the index procedure.
次要结局
- Number of Participants With Primary Assisted Patency(6 months)
- Time to Hemostasis of Suture Hole Bleeding (Min)(Post-procedure)
- Number of Participants With Secondary Patency(6 months)