SeCure Endovenous Laser Treatment Study

Not Applicable

Completed

• Conditions: Chronic Venous Insufficiency
• Interventions: Device: VenaCure EVLT 400 µm fiber Procedure Kit

• Registration Number: NCT02215369
• Lead Sponsor: Angiodynamics, Inc.

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 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.

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 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 Timeline

• Study First Submitted: 2014-08-08
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-13
• Study Start: 2015-01
• Primary Completion: 2018-03
• Study Completion: 2019-01-14
• Results First Submitted: 2020-04-07
• Results First Submitted QC: 2020-04-07
• Results First Posted: 2020-04-21
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VenaCure EVLT 400 µm fiber Procedure Kit	VenaCure EVLT 400 µm fiber Procedure Kit	Only one limb can be treated and included in this study; however, multiple IPV's within the study limb may be treated. All IPV's treated will be followed according to the study schedule.

Primary Outcome Measures

Name	Time	Method
Acute Primary Ablation Success	10 day	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.

Secondary Outcome Measures

Name	Time	Method
Technical Success	Treatment	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.

Trial Locations

Locations (7)

Midwest Institute for Minimally Invasive Therapies; 🇺🇸 Melrose Park, Illinois, United States

The Vein Center of Virginia; 🇺🇸 Norfolk, Virginia, United States

Vein Clinics of America; 🇺🇸 Orland Park, Illinois, United States

Englewood Hospital and Medical Center; 🇺🇸 Englewood, New Jersey, United States

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Lake Washington Vascular; 🇺🇸 Bellevue, Washington, United States

NYU Langone Medical Center; 🇺🇸 New York, New York, United States