Venclose RF Ablation System for the Treatment of IPVs

Study Overview
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Brief Summary
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A feasibility study conducted in patients with incompetent (i.e. refluxing) perforator veins were treated using the Venclose RF Ablation System.

Official Title
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Investigator Initiated Safety Study Using the Venclose Vestico (Commercial Name TBD) Radiofrequency (RF) Ablation System for the Treatment of Incompetent Perforator Veins (IPVs)

Conditions
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Chronic Venous Insufficiency

Intervention / Treatment
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* Device: Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-arm: Endovascular thermal ablation in IPV<br> | Device: Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins<br>* The physician operator will access the IPV and advance the device to the target treatment position using ultrasound guidance. After providing local anesthesia to the vein and surrounding tissues, thermal ablation energy is delivered to the vein wall. After treatment is complete, the device is removed and vessel closure confirmed with duplex ultrasound.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: AEs, SAEs, ADEs, SADEs, UADEs | 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. | 3-day post-procedure | 
| Safety: AEs, SAEs, ADEs, SADEs, UADEs | 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. | 15-day post-procedure | 
| Safety: AEs, SAEs, ADEs, SADEs, UADEs | 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. | 30-day post-procedure | 
| Effectiveness: Technical Success | 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. | Day of procedure | 
| Effectiveness: Successful Access and Entry Into the IPV | 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. | 3-day post ablation | 
| Effectiveness: Technical Success | 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. | 15-day post ablation | 
| Effectiveness: Technical Success | 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. | 30-day post ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Ablation Success | The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure. | 3-day post-procedure follow-up | 
| Acute Ablation Success | The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure. | 15-day post-procedure | 
| Acute Ablation Success | The acute ablation success endpoint is defined as complete lack of flow or IPV disappearance in the treated segment (vessel occlusion). Success will be measured by Duplex Ultrasound imaging post-procedure. | 30-day post-procedure | 
| Reflux | Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point. | 3-day post-procedure | 
| Reflux | Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point. | 15-day post-procedure | 
| Reflux | Presence of reflux in the treated IPV will be recorded at each time point and an overall absence of reflux rate (i.e. reflux free rate) will be documented at each follow-up time point. | 30-day post-procedure |