Status:
WITHDRAWN
Comparison Study for Safety and Efficacy of Two Devices for the Treatment of the Great Saphenous Vein
Lead Sponsor:
Angiodynamics, Inc.
Conditions:
Varicose Veins
Venous Insufficiency
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 symp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01173419
Start Date
July 1 2010
End Date
February 1 2012
Last Update
July 13 2012
Active Locations (6)
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1
UC Davis Interventional and Vascular Radiology
Sacramento, California, United States, 95817
2
Batey Cardiovascular and Vein Center
Bradenton, Florida, United States, 34209
3
Midwest Institute for Minimally Invasive Therapies (MIMIT)
Melrose Park, Illinois, United States, 60160
4
Novi Vein Center
Novi, Michigan, United States, 48377