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

Withdrawn before enrolling · Not applicable

Conditions studied: Varicose Veins, Venous Insufficiency

In brief

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.

Key facts

Study ID

NCT01173419

Run by

Angiodynamics, Inc.

People needed

0

Starts

2010-07-01

Expected to finish

2012-02-01

Last updated by the study team

2012-07-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• UC Davis Interventional and Vascular Radiology — Sacramento, California, United States
• Batey Cardiovascular and Vein Center — Bradenton, Florida, United States
• Midwest Institute for Minimally Invasive Therapies (MIMIT) — Melrose Park, Illinois, United States
• Novi Vein Center — Novi, Michigan, United States
• NYU Langone Medical Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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