Investigator Initiated Safety Study Using the Venclose Vestico (Commercial Name TBD) Radiofrequency (RF) Ablation System for the Treatment of Incompetent Perforator Veins (IPVs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Safety: AEs, SAEs, ADEs, SADEs, UADEs
研究概览
简要总结
A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.
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
- •Patient is >= 18 years.
- •IPVs to be treated have an outward flow duration of >= 0.5 seconds immediately after release of manual distal compression with patient standing or in Reverse Trendelenburg.
- •IPV(s) to be treated have a diameter of ≥ 3.5 mm located caudal edge of ankle.
- •Has been diagnosed with refractory symptomatic disease attributable to the IPV to be treated.
- •Is able to ambulate.
- •Is able to comprehend and has 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
- •Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site.
- •Has thrombus in the vein segment to be treated.
- •Has untreated critical limb ischemia from peripheral arterial disease.
- •Is undergoing active anticoagulant therapy for Deep Vein Thrombosis or other conditions (e.g., warfarin, direct oral anticoagulant or low molecular weight heparin) or has a history of Deep Vein Thrombosis within the last 6 months or hypercoagulable state.
- •Patients with known bleeding or clotting disorders or unwilling or unable to frequently ambulate post-operatively.
- •Has had prior venous procedures in the study limb within the last 30 days (including thrombolysis, thrombectomy, stenting, ablation, phlebectomy, visual or foam sclerotherapy).
- •Has undergone or is expected to undergo any major surgery within 30 days prior to or 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 30 days following the study procedure.
- •Is participating in another clinical study that is contraindicated to the treatment or outcomes of this investigation
结局指标
主要结局
Safety: AEs, SAEs, ADEs, SADEs, UADEs
时间窗: 30-day post-procedure
Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE) and unanticipated adverse device effects (UADE) will be monitored analyzed for acceptability post study.
Effectiveness: Technical Success
时间窗: 30-day post ablation
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
Effectiveness: Successful Access and Entry Into the IPV
时间窗: 3-day post ablation
Technical success defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended energy to the target vein segment, will be evaluated.
次要结局
- Reflux(30-day post-procedure)
- Acute Ablation Success(30-day post-procedure)