Chronic Venous Insufficiency
Conditions
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.
Interventions
DEVICEVenaCure 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.
Sponsors
Angiodynamics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Primary Ablation Success | 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
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 83 |
| Total | 83 |
Baseline characteristics
| Characteristic | VenaCure EVLT 400 µm Fiber Procedure Kit |
|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 12.2 |
| BMI | 30.2 kg/m^2 STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 73 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 93 |
| other Total, other adverse events | 26 / 93 |
| serious Total, serious adverse events | 9 / 93 |
Outcome results
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.
Time frame: 10 day
Population: Intent to Treat (ITT) Population
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| VenaCure EVLT 400 µm Fiber Procedure Kit | Acute Primary Ablation Success | 96 Veins |
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.
Time frame: Treatment
Population: Intent to Treat (ITT) Population
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| VenaCure EVLT 400 µm Fiber Procedure Kit | Technical Success | 119 Veins |