NCT01930071已完成不适用
PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Endologix
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Primary Patency
研究概览
简要总结
To assess the safety of performing a percutaneous fem-pop bypass using the PQ Bypass Guidewire Delivery System and commercially available stent grafts.
详细描述
Multi-center, single-arm first-in-man study utilizing the PQ Bypass Guide Wire Delivery System to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.
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
- •Willing and able to provide informed consent
- •Age 18 or older
- •Rutherford Classification of 3-5
- •Lesions ≥10cm in length considered to be:
- •Chronic total occlusion (100% stenosis)
- •Diffuse stenosis (>50% stenosis) with moderate to heavy calcification
- •In-stent restenosis (>50% stenosis)
- •Proximal and distal target vessels are 4.8 - 7.5 mm in diameter
- •Orifice and proximal 1cm of SFA is patent
- •Patent popliteal artery 3cm proximal to tibial plateau
- •At least 1 patent tibial artery to the foot
- •Patent femoral vein
排除标准
- •History of deep vein thrombosis
- •Has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated
- •Has a known sensitivity or allergy to aspirin, heparin or anti-platelet medications
- •Documented in-sensitivity to anti-platelet medication
- •Has a known or previous coagulopathy
- •Pregnant or lactating
- •Untreated flow-limiting aortoiliac occlusive disease
- •Has renal failure (GFR < 30mL/min)
- •Major distal amputation (above the transmetatarsal) in the study or non-study limb
- •Patient has had a procedure on the target limb within 30 days
- •Previous bypass surgery on the target limb
- •Bypass length required is greater than 35cm
研究组 & 干预措施
PQ Bypass Guide Wire Delivery System
Experimental
PQ Bypass Guide Wire Delivery System to complete percutaneous Fem-pop bypass
干预措施: PQ Bypass Guide Wire Delivery System (Device)
结局指标
主要结局
Primary Patency
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (1)
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