SeCure Endovenous Laser Treatment Study

NCT02215369 | Completed Results

• 1 other identifier: PV-VC300
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 7

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.

Conditions

Chronic Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Technical Success

  Treatment

Study Arms (1)

VenaCure EVLT 400 µm fiber Procedure Kit

EXPERIMENTAL

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

Interventions

VenaCure EVLT 400 µm fiber Procedure Kit DEVICE

The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.

VenaCure EVLT 400 µm fiber Procedure Kit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

Study Sites (7)

Midwest Institute for Minimally Invasive Therapies

Melrose Park, Illinois, 60160, United States

Location

Vein Clinics of America

Orland Park, Illinois, 60462, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

The Vein Center of Virginia

Norfolk, Virginia, 23507, United States

Location

Lake Washington Vascular

Bellevue, Washington, 98004, United States

Location

Related Publications (1)

• 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.

  PMID: 32205128 DERIVED

Results Point of Contact

• Title: Ariel Bloch
• Organization: Angiodynamics

abloch@angiodynamics.com

7742453646

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 13, 2014
• Study Start: January 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: January 14, 2019
• Last Updated: May 19, 2020
• Results First Posted: April 21, 2020

Record last verified: 2020-05

Locations

US (7)