SeCure Endovenous Laser Treatment Study

Angiodynamics, Inc.112 enrolled

Overview

The VenaCure EVLT 400 µm Fiber Kit is currently marketed for the treatment of varicose veins. AngioDynamics, Inc., the company that manufacturers the VenaCure device, is sponsoring this study to assess the safety and effectiveness of the VenaCure EndoVenous Laser Treatment (EVLT) 400 µm Fiber Kit for treatment of incompetent perforator veins (IPVs). The VenaCure EVLT 400 µm Fiber Kit has not been previously studied by AngioDynamics for the ablation of IPVs.

This is a single-arm, prospective, multicenter, non-blinded clinical trial. Study data will be summarized and submitted to the FDA in a premarket notification once all treated subjects have completed the 3 month visit. Longer term followup is being performed for publication purposes. Patients diagnosed with incompetent Perforator Veins (IPV's) and meet all inclusion and none of the exclusion criteria will be eligible for this study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Chronic Venous Insufficiency

Interventions

VenaCure EVLT 400 µm fiber Procedure KitDEVICE

The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

INCLUSION CRITERIA Patients are required to fulfill all the following criteria to be included in the study: 1. Is ≥ 18 years of age 2. IPV(s) to be treated have an outward flow duration of ≥ 0.5 sec immediately after manual release of manual compression 3. IPV(s) to be treated have a diameter of ≥ 3.5 mm (measured at the level of the fascia) located superior to foot and distal ankle 4. Has been diagnosed with refractory symptomatic disease (CEAP Class 4b to Class 6) attributable to the IPV to be treated 5. Has palpable pedal pulses in the study limb 6. Any pathologic superficial saphenous veins have been previously eliminated and were done so at least more than 30 days prior to the study procedure 7. Is able to ambulate 8. Is able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study 9. Is willing and able to comply with the Clinical Investigation Plan and follow-up schedule EXCLUSION CRITERIA Patients will be excluded from participation in the study if they meet any of the following: 1. Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site 2. Has thrombus in the vein segment to be treated 3. Has known peripheral arterial disease 4. Has a BMI calculation (BMI = W / H2 ) ≥40kg/m2 5. Is undergoing active anticoagulant therapy for Deep VeinThrombosis or other conditions (e.g., warfarin, Q10 inhibitors or low molecular weight heparin) or has a history of Deep Vein Thrombosis within the last 6 months or hypercoagulable state. 6. Has had prior venous procedures in the study limb within the last 30 days (including but not limited to, thrombolysis / thrombectomy / stenting / ablation / phlebectomy / sclerotherapy) 7. Has undergone or is expected to undergo any major surgery within 30 days prior to or within 90 days following the study procedure 8. 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 9. Is pregnant or lactating at the time of the study procedure or is intending on becoming pregnant within 90 days following the study procedure 10. Is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation

Locations (7)

Midwest Institute for Minimally Invasive Therapies

Melrose Park, Illinois, United States

Vein Clinics of America

Orland Park, Illinois, United States

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

NYU Langone Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Acute Primary Ablation Success

The primary effectiveness endpoint is "Acute Primary Ablation Success" defined as complete lack of flow or IPV disappearance in the entire treated segment. Success will be measured via Duplex Ultrasound imaging performed 10 days (± 3 days) post procedure. Primary ablation success must be measured by a physician other than the physician that performed the study procedure.

Time frame: 10 day

Secondary Outcomes

Technical Success

Technical Success, defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended laser energy, will be evaluated as a secondary endpoint for inclusion in device labeling.

Time frame: Treatment

Data from ClinicalTrials.gov

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