NCT04625660已完成不适用
The DETOUR2 Continued Access Clinical Trial - The Detour Endovascular Technique for Long OcclUsive Fem-pop Revascularization - Continued Access Clinical Trial
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
- 11
- 试验地点
- 3
- 主要终点
- Primary Safety Endpoint at 30 Days
研究概览
简要总结
Prospective, single-arm, multi-center, clinical investigation to continue to evaluate the safety and effectiveness of the PQ Bypass 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria
- •Age > 18 and ≤ 90 years of age.
- •Willing and able to provide informed consent.
- •Subject is willing to undergo all follow-up assessments according to the specified schedule over 24 months.
- •Clinical Inclusion Criteria
- •Chronic, symptomatic lower limb ischemia defined as Rutherford clinical categories 3, 4, or
- •Venous Clinical Severity Score <
- •Subject is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair.
- •Angiographic Inclusion Criteria
- •Symptomatic femoropopliteal chronic total occlusions ≥ 20 cm that can include de novo, restenotic, or in-stent restenotic lesions; or Symptomatic femoropopliteal lesions ≥ 24 cm (total lesion length) that can include a chronic total occlusion or a
- •70% lesion that includes de novo, restenotic or in-stent restenosis, by investigator visual assessment.
- •Reference vessel diameter ≥ 4.5 and ≤ 6.7 mm, by investigator visual assessment.
- •Subject has a patent popliteal artery (<50% stenosis) distal to the landing zone
- •Able to successfully access the SFA origin for entry of the crossing device.
- •At least one patent infrapopliteal vessel (<50% stenosis) with run-off to the ankle or foot.
- •A significant stenosis (≥ 50%) or occlusion of an ipsilateral, inflow artery (e.g.
- •aortoiliac, common femoral) must be successfully treated (use of investigational treatment prohibited) prior to treatment of the target lesion. Successful treatment is defined as no complications and less than 30% residual stenosis following intervention.
排除标准
- •Participating in another investigational clinical study that has not reached the study endpoint or interferes with endpoints of this study
- •Anticipated life expectancy less than 1 year or medical comorbid condition(s) that could limit the subject's ability to comply with the requirements of the trial.
- •Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
- •Clinical Exclusion Criteria
- •History of deep vein thrombosis the target limb.
- •Thrombophlebitis, within the previous 30 days.
- •Planned or previous major amputation of the target limb.
- •Known or suspected active infection at the time of the procedure (e.g., WIfI foot infection grade 3: Severe infection. Local infection with systemic inflammatory response syndrome [SIRS]).
- •Rutherford clinical category 0, 1, 2 or
- •Has acute or chronic renal disease with GFR ≤ 30 ml/min per 1.73 m2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L) or on dialysis.
- •Known hypersensitivity/allergy to the investigational devices and/or required pharmacotherapy that cannot be safely managed.
- •Morbid obesity that does not allow for safe vascular access, adequate imaging, or impacts to mobility.
- •Subject has a known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR > 1.
- •Any planned vascular interventions within 14 days before and/or 30 days following the index procedure (successful inflow treatment is permitted prior to enrollment).
- •Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 3 months.
- •Subject is pregnant or breast-feeding.
- •Angiographic Exclusion Criteria
- •Stent within 3 cm of SFA ostium.
- •Previous bypass surgery on the target limb that would inhibit adequate crossing proximally and distally. (e.g. the SFA artery was ligated during the bypass surgery).
- •Subject has significant disease or obstruction (≥50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as
- •30% residual stenosis, without complication)
- •Presence of aneurysm or acute thrombus in the target limb.
- •Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
研究组 & 干预措施
Single Arm
Experimental
The PQ Bypass system is used during a minimally invasive procedure to place stent grafts in the peripheral vasculature to improve blood flow.
干预措施: PQ Bypass System (Device)
结局指标
主要结局
Primary Safety Endpoint at 30 Days
时间窗: 30 Days
Freedom from a major adverse event (MAE) at 30 days post-procedure defined as any occurrence of the following events: Death, Clinically-Driven Target Lesion Revascularization (CD-TLR), Major Amputation of the Treated Limb, Symptomatic Deep Vein Thrombosis (DVT), or Pulmonary Embolism, or procedure-related bleeding requiring any transfusion of packed red blood cells or surgery.
Primary Effectiveness Endpoint - Patency at 12 Months
时间窗: 12 Months
The absence of clinically-driven target lesion revascularization and absence of recurrent target lesion diameter stenosis \>50% by imaging (e.g., duplex ultrasound peak systolic velocity ratio of \>2.5 or invasive angiography) within the stent or immediately 1 cm above or below the treated segment. When both modalities are available, angiography takes precedence.
次要结局
未报告次要终点
研究者
研究点 (3)
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