Venclose RF Ablation System for the Treatment of IPVs

Not Applicable

Completed

Interventions: Device: Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Single-arm: Endovascular thermal ablation in IPV	Radiofrequency (RF) Thermal Ablation of Incompetent Perforator Veins	-

Primary Outcome Measures

Name	Time	Method
Safety: AEs, SAEs, ADEs, SADEs, UADEs	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Reflux	30-day post-procedure	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.
Acute Ablation Success	30-day post-procedure	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.