Status:
COMPLETED
SeCure Endovenous Laser Treatment Study
Lead Sponsor:
Angiodynamics, Inc.
Conditions:
Chronic Venous Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 asses...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Patients are required to fulfill all the following criteria to be included in the study:
- Is ≥ 18 years of age
- IPV(s) to be treated have an outward flow duration of ≥ 0.5 sec immediately after manual release of manual compression
- 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
- Has been diagnosed with refractory symptomatic disease (CEAP Class 4b to Class 6) attributable to the IPV to be treated
- Has palpable pedal pulses in the study limb
- Any pathologic superficial saphenous veins have been previously eliminated and were done so at least more than 30 days prior to the study procedure
- Is able to ambulate
- Is able to comprehend and have 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
- Patients will be excluded from participation in the study if they meet any of the following:
- Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site
- Has thrombus in the vein segment to be treated
- Has known peripheral arterial disease
- Has a BMI calculation (BMI = W / H2 ) ≥40kg/m2
- 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.
- 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)
- Has undergone or is expected to undergo any major surgery within 30 days prior to or within 90 days 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 90 days following the study procedure
- Is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation
Exclusion
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2019
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT02215369
Start Date
January 1 2015
End Date
January 14 2019
Last Update
May 19 2020
Active Locations (7)
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1
Midwest Institute for Minimally Invasive Therapies
Melrose Park, Illinois, United States, 60160
2
Vein Clinics of America
Orland Park, Illinois, United States, 60462
3
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
4
NYU Langone Medical Center
New York, New York, United States, 10016