NCT05504070进行中（未招募）不适用
Venclose digiRF System: A Post-Market, Multi-Center, Prospective, Interventional Study for Treatment of Chronic Venous Disease of the Great and Small Saphenous Veins and Incompetent Perforator Veins
C. R. Bard7 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2023年9月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 203
- 试验地点
- 7
- 主要终点
- Occlusion
研究概览
简要总结
A Post-Market, Multi-Center, Prospective, Interventional Study for Treatment of Chronic Venous Disease of the Great and Small Saphenous Veins and Incompetent Perforator Veins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Subject is age 18 and older
- •Subject has CEAP clinical class C2 and higher.
- •Has been diagnosed with refractory symptomatic disease attributable to the GSV/SSV or IPV to be treated.
- •GSV/SSV or IPV to be treated that has an outward flow reflux duration of ≥ 0.5 seconds immediately after release of manual distal compression with subject standing or in Reverse Trendelenburg.
- •For GSV/SSV cohort only: GSV/SSV to be treated in a leg that has a diameter ≥4.5 mm.
- •For IPV cohort only: no more than two IPVs to be treated in a leg that have a diameter of ≥ 3.5 mm.
- •For IPV only: IPVs must be located under a healed or active ulcer.
- •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 had previous treatment for venous insufficiency in the same target vein.
- •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 acute 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.
- •Subjects with known bleeding and/or clotting disorders.
- •Has ABI <0.8
- •Subject is pregnant or breastfeeding
- •For GSV/SSV only: has a BMI >
- •For SSV only: has refluxing small saphenous vein thigh extensions (ex. Giacomini vein).
- •Unable to ambulate, or restrictive ambulation.
- •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 subject's well-being and/or confound the results or the soundness of the study.
研究组 & 干预措施
GSV/SSV
Experimental
Incompetent Great and Small Saphenous Veins
干预措施: Venclose System (digiRF generator w EVSRF catheter) (Device)
IPV
Experimental
Incompetent Perforator Veins
干预措施: Venclose MAVEN System (digiRF generator w MAVEN catheter) (Device)
结局指标
主要结局
Occlusion
时间窗: 1-Month
Cumulative Incidence of Occlusion
DVT & PE Serious Adverse Events
时间窗: 1-Month
Cumulative Incidence of Device and Procedural Related Deep venous thrombosis \& Pulmonary Embolism Serious Adverse Events
次要结局
- Clinical Etiological Anatomical Pathophysiological (CEAP)(Baseline, 1-Week (+/- 2 days), 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days), and 12- and 24-Month (+/- 30 days) visits)
- Duration of Procedure(Day 1 Index Procedure visit)
- Visual Analog Scale for Pain (VAS)(Baseline, Day 1 Index Procedure, 1-Week (+/- 2 days), 1-Month (+ 7 days), and 3-Month (+/- 14 days) visits)
- Recanalization(1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12-Month (+/- 14 days) visits)
- revised Venous Clinical Severity Score (rVCSS)(Baseline, 1-Week (+/- 2 days), 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days), and 12- and 24-Month (+/- 30 days) visits)
- ChronIc Venous Insufficiency Questionnaire - 20 (CIVIQ-20)(Baseline, 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12- and 24-Month (+/- 30 days) visits)
- Endovenous Heat Induced Thrombosis (2-4)(1-Month (+7 days) visit)
研究者
研究点 (7)
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