Venclose RF Ablation System for the Treatment of IPVs

Venclose

Status: Completed

Conditions: Chronic Venous Insufficiency

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04386785

CL-VAV-001

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Single-arm: Endovascular thermal ablation in IPV

Experimental group

Treatment:

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