Comparison Study for Safety and Efficacy of Two Devices for the Treatment of the Great Saphenous Vein

A Multi-Center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Subjects Comparing the NeverTouch Versus the RF ClosureFAST Methods of Treatment of the Great Saphenous Vein

This is a multi center, randomized, comparison study using two already cleared methods of treatment of the great saphenous vein (GSV). The hypothesis to be tested is that the use of the Venacure EVLT NeverTouch procedure is no worse than the RF ClosureFAST procedure for treatment of the GSV. Evaluation of post operative pain and bruising, quality of life assessments, adverse event assessments, confirmation of long term GSV closure, use of medications are criteria that will be evaluated during the course of this study.

Some form of venous insufficiency affects up to 25% of men and 40% of women in the United States. While most persons seek treatment because varicose veins are unsightly, most will also experience symptoms such as aching pain, night cramps, leg fatigue, leg heaviness or leg restlessness. If left untreated, nearly 50% of patients with significant superficial venous insufficiency will experience chronic venous insufficiency characterized by lower extremity swelling, eczema, pigmentation, hemorrhage and ulceration.

This is a multicenter, prospective, randomized study in subjects with symptomatic venous insufficiency of the great saphenous vein. Subjects evaluated for participation will be those who, prior to the first visit, have elected to receive invasive treatment for the GSV insufficiency and have already received conservative treatment (i.e. use of compression hose).

Subjects will be randomized to receive one of two methods of treatment. VenaCure EVLT NeverTouch method of treatment or the RF ClosureFAST method of treatment.

Follow up visits will take place at 2, 7, 14 and 30 days post treatment where questionnaires (SF-36, CIVI Q2, Visual Analogue Scale), evaluation of GSV closure via duplex ultrasound (7 day and 30 day only), evaluation of ecchymosis, physician (or their designee) evaluation of venous disease (CEAP assessment and VCSS assessment), assessments of adverse events and review of concomitant medications (use of analgesics and other medications)will take place. These same evaluations with the exception of the use of the Visual Analogue Scale and the Ecchymosis evaluation will also take place at the 6 month and 12 month follow up visit timepoints.

Inclusion Criteria:

• male or female,
• 18 to 80 years of age,
• have documented symptomatic GSV disease defined by any of the following:
• C2 disease
• C3 disease
• C4A, C4B disease
• C5 disease
• C6 disease
• have not been previously treated for GSV,
• have multilevel venous reflux in the great saphenous vein greater than 0.5 seconds after distal compression/ release in the standing position,
• have palpable dorsalis pedis/ anterior tibial pulse or ABI >0.9 (unless calcified pressures) at screening,
• are able to comply with the protocol requirements,
• are able to comprehend and willing to sign an Informed Consent Form (ICF).

Exclusion Criteria:

• has had a previous venous intervention on the same leg as planned current treatment,
• are in a known hypercoagulable state,
• have deep vein thrombosis or a history of deep vein thrombosis,
• have thrombus within the last three months in the vein segment to be treated,
• have an aneurysmal section in the vein segment to be treated (aneurysm is defined as 2 times greater than the adjacent vein),
• are not able to ambulate,
• have non staged adjunctive procedures such as sclerotherapy and/ or ambulatory phlebectomy. May elect to stage the procedure from the initial script, and not treat before the 30 day follow up visit is completed.
• are, in the opinion of the investigator, unable to comply with the schedule and protocol evaluations,
• are currently pregnant or breast feeding,
• have a known malignancy other than skin cancer,
• current use of anticoagulant medication,
• have any condition which in the opinion of the investigator could compromise subject safety or adherence to the protocol,
• has had treatment with any investigational agent within 30 days of visit 1.