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SeCure Endovenous Laser Treatment Study (SeCure)

Primary Purpose

Chronic Venous Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VenaCure EVLT 400 µm fiber Procedure Kit
Sponsored by
Angiodynamics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Venous Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Midwest Institute for Minimally Invasive Therapies
  • Vein Clinics of America
  • Englewood Hospital and Medical Center
  • NYU Langone Medical Center
  • UPMC
  • The Vein Center of Virginia
  • Lake Washington Vascular

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VenaCure EVLT 400 µm fiber Procedure Kit

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 8, 2014
Last Updated
May 6, 2020
Sponsor
Angiodynamics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02215369
Brief Title
SeCure Endovenous Laser Treatment Study
Acronym
SeCure
Official Title
Prospective Safety and Effectiveness Study: VenaCure Endovenous Laser Treatment (EVLT) 400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
January 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angiodynamics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VenaCure EVLT 400 µm fiber Procedure Kit
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VenaCure EVLT 400 µm fiber Procedure Kit
Intervention Description
The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.
Primary Outcome Measure Information:
Title
Acute Primary Ablation Success
Description
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.
Time Frame
10 day
Secondary Outcome Measure Information:
Title
Technical Success
Description
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.
Time Frame
Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Midwest Institute for Minimally Invasive Therapies
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
Facility Name
Vein Clinics of America
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60462
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
The Vein Center of Virginia
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Lake Washington Vascular
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32205128
Citation
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.
Results Reference
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SeCure Endovenous Laser Treatment Study

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