The Complete® SE SFA Study: The Medtronic Complete Self-Expanding SFA Stent System for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and/or Proximal Popliteal Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 8
- 主要终点
- Major Adverse Event (MAE) Rate
研究概览
简要总结
To evaluate the safety and efficacy of the Complete SE SFA Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).
详细描述
The Complete Self-Expanding (SE) SFA Stent is designed to be a permanent implant. It is cut from a nickel titanium alloy (Nitinol) tube and consists of a series of segments each connected to the next in a unique pattern to allow for flexibility and vessel conformability. Each segment consists of two struts and a crown (Figure 1). It is designed to produce optimal luminal diameter and increased scaffolding, and to maintain luminal 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rutherford 2-4, with an occlusion or de novo and/or restenotic SFA/PPA lesion ≥50% and ankle-brachial index/toe-brachial index (ABI/TBI) <0.90/0.
- •Target lesion located at least 1 cm distal to the take-off of the profunda femoris artery and at least 3 cm proximal to the highest point of the cortical margin of the femur;
- •Target vessel reference diameter is ≥4.0 mm and ≤7.0 mm (visual estimate);
- •Target lesion length is ≥4.0 cm and ≤14.0 cm (visual estimate);
- •Adequate distal run-off to the ankle in the target limb (defined as having at least one patent calf vessel <50% stenosed;
- •Life expectancy >12 months.
排除标准
- •Women who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment;
- •Any condition that precludes safe access with percutaneous transluminal angioplasty (PTA) devices, such as: excessive peripheral artery disease, unresolved fresh thrombus in the target lesion/vessel, or a target lesion/vessel that is excessively tortuous or calcified;
- •Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
- •Previous treatment to the target lesion within the 3 months prior to enrollment; previous femoropopliteal bypass in target vessel; previous stenting of the target lesion;
- •Target lesion located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion;
- •Target lesion requires treatment other than standard PTA prior to stent placement (i.e., no other devices or procedures such as cutting balloons and laser atherectomy are permitted to be used during the index procedure);
- •History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
- •Known impaired renal function, defined as creatinine >2.5 mg/dl;
- •Known platelet count <80,000 cells/mm3 or >700,000 cells/mm3;
- •Known white blood cell (WBC) of <3,000 cells/mm3;
- •Participation in another investigational device or drug study and has not completed the primary endpoint(s) or which clinically interferes with the Complete SE SFA Study endpoints, or previously enrolled in the Complete SE SFA Study.
结局指标
主要结局
Major Adverse Event (MAE) Rate
时间窗: 12 Months
Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization.
Primary Patency Rate
时间窗: 12 Months
Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS).
次要结局
- Major Adverse Event (MAE) Rate(36 Months)
- Device Success(At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).)
- Lesion Success(At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).)
- Procedure Success(At time of deployment to time of hospital discharge)
- Assisted Primary Patency(12 months)
- Secondary Patency Rate(12 Months)
- Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category(12 months)
- Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15(12 Months)
- Change in Quality of Life - Decrease in Rutherford Class >= 1 Category(30 Days)
- Percentage of Participants Free From Strut Fractures(36 Months)
- Clinically-driven Target Lesion Revascularization (TLR) Rate(12 Months)