PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Endologix
- 入组人数
- 78
- 试验地点
- 8
- 主要终点
- Number of Lesions With Primary Patency
研究概览
简要总结
To assess the safety and performance of the PQ Bypass System to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
详细描述
Prospective, single-arm, multi-center, international, non-randomized, pre-market, safety and effectiveness clinical investigation evaluating the PQ Bypass Systems 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 90 Years（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
- •Patent iliac and femoral arteries/veins and access vessels, of sufficient size and morphology (including tortuosity), to allow endovascular access with 8 Fr. introducer sheath
- •Femoro-popliteal lesions ≥10 cm 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 5.4-7.0 mm in diameter
- •Orifice and proximal 1 cm of SFA is patent
- •Patent popliteal artery 3 cm proximal to tibial plateau
- •At least 1 patent tibial artery to the foot
- •Patent femoral vein ≥ 10 mm in diameter or duplicate femoral vein
- •Subject has > one year life expectancy
排除标准
- •Bypass length required > 30 cm
- •History of deep vein thrombosis
- •Has a known hypersensitivities, allergies or contraindications to: nitinol, PTFE; aspirin, heparin, antiplatelet, anticoagulant or thrombolytic therapy; or anticoagulation or contrast media that is not amenable to pre-treatment;
- •Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 12 months
- •Pregnant or nursing
- •Untreated flow-limiting aortoiliac occlusive disease
- •Has renal failure (eGFR < 30mL/min)
- •Major distal amputation (above the transmetatarsal) in the study or non-study limb
- •Patient has had a revascularization procedure on the target limb within 30 days
- •Patient has a planned amputation of the target limb
- •Previous bypass surgery on the target limb
- •Patient is participating in another clinical study for which follow-up is currently on going.
- •Patient has a condition that in the view of the investigator precludes participation in this study
研究组 & 干预措施
Single arm study
PQ Bypass System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass
干预措施: PQ Bypass System for Femoropopliteal Bypass (Device)
结局指标
主要结局
Number of Lesions With Primary Patency
时间窗: 6 Months
Rate of primary patency. Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of \>2.5).
Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure
时间窗: One Month
composite endpoint of death, CD-TVR, or major target limb amputation in all patients at One-month post procedure
次要结局
- Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb(One Month)
- Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure(One Month)
- Percentage of Lesions With Primary Patency at 12 Months Post-Procedure(12 Months)
- Number of Major Adverse Events at the 12-Month Time Point(12 Months)
- Number of Major Adverse Events at the 3 Year Time Point(3 Years)
- Major Adverse Vascular Event (MAVE) Rate(One Month)
- Major Adverse Vascular Event (MAVE) Rate at 3 Years(3 Years)