SeCure Endovenous Laser Treatment Study

NCT ID: NCT02215369

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-01-14

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.

Conditions

Chronic Venous Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

VenaCure EVLT 400 µm fiber Procedure Kit

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Angiodynamics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Midwest Institute for Minimally Invasive Therapies

Melrose Park, Illinois, United States

Vein Clinics of America

Orland Park, Illinois, United States

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

NYU Langone Medical Center

New York, New York, United States

UPMC

Pittsburgh, Pennsylvania, United States

The Vein Center of Virginia

Norfolk, Virginia, United States

Lake Washington Vascular

Bellevue, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32205128 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PV-VC300

Identifier Type: -

Identifier Source: org_study_id