Study of PERipheral Bypass GraFting: ProspECTive Evaluation of FUSION™ Vascular Graft for Above Knee Targets(PERFECTION)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 117
- 试验地点
- 20
- 主要终点
- Participants With Primary Graft Patency at 12 Months
研究概览
简要总结
The purpose of the post-market study was to evaluate the safety and performance of the FUSION Vascular Graft.
详细描述
This study was a prospective, single-arm, multicenter study conducted in Germany and Austria to evaluate the FUSION Vascular Graft in patients with peripheral arterial occlusive disease undergoing above-the-knee bypass. Follow-up visits were performed at 30 days, 6 months, 12 months and included patency and post operative complications not associated with bypass patency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No known malignant disease
- •Patient was willing and able to have follow-up visits and examinations
- •Peripheral arterial occlusive disease (PAOD) requiring treatment of the femoral artery; Fontaine stage IIb, III and IV with dry peripheral gangrene, and suitable for surgery
- •Patient was not participating in other clinical trials that would conflict with this protocol
- •Patient agreed to the study provisions and provided written informed consent
排除标准
- •Urgent or emergent surgery of any kind
- •Documented acute or suspected systemic infection
- •Life expectancy of less than one year
- •Patients who had a minor or major stroke within 6 weeks of the procedure or who had evidence of prior massive stroke
- •Patients who had experienced a myocardial infarction within 6 weeks prior to the procedure or had unstable angina pectoris
- •Severe chronic renal insufficiency or undergoing hemodialysis
- •Patients treated with coumadin (warfarin) that had not been stopped within 72 before enrollment
- •Medical conditions requiring oral anticoagulation
- •Antiplatelet therapy with clopidogrel or dual antiplatelet as well as any other antithrombotic medication within 7 days prior to scheduled bypass surgery except unfractionated heparin or aspirin
- •International normalized ratio (INR) > 2.0
- •Known hypersensitivity to heparin
- •Patient not tolerating aspirin
- •Previous history of bypass surgery in the target limb
- •Patient with category 6 ischemia (tissue loss)
- •Acute limb ischemia of any grade (0-3)
- •Patient with no outflow beyond the popliteal artery
- •Pregnant or may become pregnant during the course of the study
- •Uncontrolled arterial hypertension (BP > 200 mmHg) at 2 successive readings
- •Anaemia (hemoglobin < 8 g/ml)
- •Thrombocytopenia < 50 g/L
- •Active bleeding according to clinical judgment
- •Infected wet gangrene of any size and location at the target limb
- •Compromised arterial flow
- •Patient unwilling or unable to comply with follow-up requirements
结局指标
主要结局
Participants With Primary Graft Patency at 12 Months
时间窗: 12 Months
Subjects were assessed to have had primary graft patency at 12 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 interventions. Patency was assessed by duplex ultrasound imaging.
次要结局
- Participants With Secondary Graft Patency at 12 Months(12 Months)
- Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months(30 days, 6 months, 12 months)
- Rutherford Category at 30 Days, 6 Months and 12 Months(30 days, 6 months, 12 months)
- Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death(12 Months)