Prospective Safety and Effectiveness Study: VenaCure Endovenous Laser Treatment (EVLT) 400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 7
- 主要终点
- Acute Primary Ablation Success
研究概览
简要总结
The VenaCure EVLT 400 µm Fiber Kit is currently marketed for the treatment of varicose veins. AngioDynamics, Inc., the company that manufacturers the VenaCure device, is sponsoring this study to assess the safety and effectiveness of the VenaCure EndoVenous Laser Treatment (EVLT) 400 µm Fiber Kit for treatment of incompetent perforator veins (IPVs). The VenaCure EVLT 400 µm Fiber Kit has not been previously studied by AngioDynamics for the ablation of IPVs.
详细描述
This is a single-arm, prospective, multicenter, non-blinded clinical trial. Study data will be summarized and submitted to the FDA in a premarket notification once all treated subjects have completed the 3 month visit. Longer term followup is being performed for publication purposes.
Patients diagnosed with incompetent Perforator Veins (IPV's) and meet all inclusion and none of the exclusion criteria will be eligible for this study.
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
- •Patients are required to fulfill all the following criteria to be included in the study:
- •Is ≥ 18 years of age
- •IPV(s) to be treated have an outward flow duration of ≥ 0.5 sec immediately after manual release of manual compression
- •IPV(s) to be treated have a diameter of ≥ 3.5 mm (measured at the level of the fascia) located superior to foot and distal ankle
- •Has been diagnosed with refractory symptomatic disease (CEAP Class 4b to Class 6) attributable to the IPV to be treated
- •Has palpable pedal pulses in the study limb
- •Any pathologic superficial saphenous veins have been previously eliminated and were done so at least more than 30 days prior to the study procedure
- •Is able to ambulate
- •Is able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study
- •Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule
排除标准
- •Patients will be excluded from participation in the study if they meet any of the following:
- •Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site
- •Has thrombus in the vein segment to be treated
- •Has known peripheral arterial disease
- •Has a BMI calculation (BMI = W / H2 ) ≥40kg/m2
- •Is undergoing active anticoagulant therapy for Deep VeinThrombosis or other conditions (e.g., warfarin, Q10 inhibitors or low molecular weight heparin) or has a history of Deep Vein Thrombosis within the last 6 months or hypercoagulable state.
- •Has had prior venous procedures in the study limb within the last 30 days (including but not limited to, thrombolysis / thrombectomy / stenting / ablation / phlebectomy / sclerotherapy)
- •Has undergone or is expected to undergo any major surgery within 30 days prior to or within 90 days following the study procedure
- •Has a condition, judged by the treating physician, that may jeopardize the patient's well-being and/or confound the results or the soundness of the study
- •Is pregnant or lactating at the time of the study procedure or is intending on becoming pregnant within 90 days following the study procedure
- •Is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation
研究组 & 干预措施
VenaCure EVLT 400 µm fiber Procedure Kit
Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.
干预措施: VenaCure EVLT 400 µm fiber Procedure Kit (Device)
结局指标
主要结局
Acute Primary Ablation Success
时间窗: 10 day
The primary effectiveness endpoint is "Acute Primary Ablation Success" defined as complete lack of flow or IPV disappearance in the entire treated segment. Success will be measured via Duplex Ultrasound imaging performed 10 days (± 3 days) post procedure. Primary ablation success must be measured by a physician other than the physician that performed the study procedure.
次要结局
- Technical Success(Treatment)