Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 1 of 1 for:    NCT02215369
Previous Study | Return to List | Next Study

SeCure Endovenous Laser Treatment Study (SeCure)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215369
Recruitment Status : Active, not recruiting
First Posted : August 13, 2014
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Venous Insufficiency Device: VenaCure EVLT 400 µm fiber Procedure Kit Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Safety and Effectiveness Study: VenaCure Endovenous Laser Treatment (EVLT) 400 µm Fiber Procedure Kit for Treatment of Incompetent Perforator Veins
Actual Study Start Date : January 2015
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

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.




Primary Outcome Measures :
  1. Acute Primary Ablation Success [ Time Frame: 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 :
  1. Technical Success [ Time Frame: 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.


Other Outcome Measures:
  1. Safety [ Time Frame: Duration of the study ]
    Procedure related adverse events (AE), serious adverse events (SAE), adverse device effects (ADE), serious adverse device effects (SADE), and unanticipated adverse device effects (UADE) will be followed. Device malfunctions will be reported by the investigator and reviewed by the Sponsor in compliance with applicable regulations



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215369


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

Layout table for additonal information
Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT02215369    
Other Study ID Numbers: PV-VC300
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases