SeCure Endovenous Laser Treatment Study (SeCure)

Prospective Safety and Effectiveness Study: VenaCure Endovenous Laser Treatment (EVLT) 400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins

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.

Study Overview

• Status: Completed
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Device: VenaCure EVLT 400 µm fiber Procedure Kit

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Melrose Park, Illinois, United States, 60160
      • Midwest Institute for Minimally Invasive Therapies
    • Orland Park, Illinois, United States, 60462
      • Vein Clinics of America
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital and Medical Center
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • The Vein Center of Virginia
  • Washington
    • Bellevue, Washington, United States, 98004
      • Lake Washington Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA

Patients are required to fulfill all the following criteria to be included in the study:

1. Is ≥ 18 years of age
2. IPV(s) to be treated have an outward flow duration of ≥ 0.5 sec immediately after manual release of manual compression
3. 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
4. Has been diagnosed with refractory symptomatic disease (CEAP Class 4b to Class 6) attributable to the IPV to be treated
5. Has palpable pedal pulses in the study limb
6. Any pathologic superficial saphenous veins have been previously eliminated and were done so at least more than 30 days prior to the study procedure
7. Is able to ambulate
8. Is able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study
9. 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:

1. Has venous insufficiency secondary to venous obstruction proximal to the intended treatment site
2. Has thrombus in the vein segment to be treated
3. Has known peripheral arterial disease
4. Has a BMI calculation (BMI = W / H2 ) ≥40kg/m2
5. 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.
6. 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)
7. Has undergone or is expected to undergo any major surgery within 30 days prior to or within 90 days following the study procedure
8. 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
9. Is pregnant or lactating at the time of the study procedure or is intending on becoming pregnant within 90 days following the study procedure
10. Is participating in another clinical study that is contraindicative to the treatment or outcomes of this investigation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: VenaCure EVLT 400 µm fiber Procedure Kit; The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Primary Ablation Success	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.	10 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success	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.	Treatment

Collaborators and Investigators

• Sponsor: Angiodynamics, Inc.

Publications and helpful links

General Publications

• Gibson K, Elias S, Adelman M, Hager ES, Dexter DJ, Vayuvegula S, Chopra P, Kabnick LS. A prospective safety and effectiveness study using endovenous laser ablation with a 400-mum optical fiber for the treatment of pathologic perforator veins in patients with advanced venous disease (SeCure trial). J Vasc Surg Venous Lymphat Disord. 2020 Sep;8(5):805-813. doi: 10.1016/j.jvsv.2020.01.014. Epub 2020 Mar 21.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): January 14, 2019

Study Registration Dates

• First Submitted: August 8, 2014
• First Submitted That Met QC Criteria: August 12, 2014
• First Posted (ESTIMATE): August 13, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: PV-VC300