Venclose digiRF System Post Market Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Venous Reflux, Chronic Venous Insufficiency

Intervention / Treatment
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* Device: Venclose System (digiRF generator w EVSRF catheter)
* Device: Venclose MAVEN System (digiRF generator w MAVEN catheter)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 >35. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSV/SSV<br>Incompetent Great and Small Saphenous Veins | Device: Venclose System (digiRF generator w EVSRF catheter)<br>* The Venclose System is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux.<br>|
| Experimental: IPV<br>Incompetent Perforator Veins | Device: Venclose MAVEN System (digiRF generator w MAVEN catheter)<br>* The Venclose MAVEN System is intended for use in endovascular coagulation of blood vessels in patients with perforator or tributary vein reflux.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion | Cumulative Incidence of Occlusion | 1-Month | 
| DVT & PE Serious Adverse Events | Cumulative Incidence of Device and Procedural Related Deep venous thrombosis & Pulmonary Embolism Serious Adverse Events | 1-Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| revised Venous Clinical Severity Score (rVCSS) | Distribution of rVCSS score | 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) | Distribution of CIVIQ-20 score | Baseline, 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12- and 24-Month (+/- 30 days) visits | 
| Clinical Etiological Anatomical Pathophysiological (CEAP) | Distribution of CEAP clinical class | 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 | 
| Visual Analog Scale for Pain (VAS) | Distribution of VAS Pain score | Baseline, Day 1 Index Procedure, 1-Week (+/- 2 days), 1-Month (+ 7 days), and 3-Month (+/- 14 days) visits | 
| Recanalization | Proportion of Recanalization of treated veins | 1-Month (+7 days), 3-Month (+/- 14 days), 6-Month (+/- 14 days) and 12-Month (+/- 14 days) visits | 
| Duration of Procedure | Mean Duration of Procedure | Day 1 Index Procedure visit | 
| Endovenous Heat Induced Thrombosis (2-4) | Cumulative incidence of device and procedural related endovenous heat-induced thrombosis (EHIT) Types 2-4 | 1-Month (+7 days) visit |