SeCure Endovenous Laser Treatment Study

Chronic Venous Insufficiency Clinical Trial

— SeCure  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215369
• Other study ID #: PV-VC300
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: January 14, 2019

Study information

• Verified date: May 2020
• Source: Angiodynamics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 14, 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Lake Washington Vascular	Bellevue	Washington
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	Midwest Institute for Minimally Invasive Therapies	Melrose Park	Illinois
United States	NYU Langone Medical Center	New York	New York
United States	The Vein Center of Virginia	Norfolk	Virginia
United States	Vein Clinics of America	Orland Park	Illinois
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Angiodynamics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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