Varicose Veins
Conditions
Keywords
Varicose Veins, Laser Ablation, Laser Wire Fibers
Brief summary
This trial was designed as a prospective, multi-center, randomized clinical trial of the FDA-cleared Vari-Lase Bright Tip Fiber compared to commercially available standard bare-tip laser fiber (control) to demonstrate the safety and effectiveness of laser ablation for the treatment of varicose veins associated with reflux within the great saphenous vein (GSV) and to provide additional data concerning patient satisfaction. Within this evaluation, subject limbs were randomized to one of two (2) treatment groups utilizing a 1:1 randomization ratio. If a subject required treatment of only one limb, that limb was randomized to a treatment group. If a subject required treatment of two limbs, the first limb was randomly assigned treatment and the second limb was assigned the other treatment (the opposite treatment of the other limb). The data was analyzed by treated limb (versus treated subject).All study data were analyzed under the principles of intent-to-treat, in which data are analyzed according to the assigned randomized group regardless of the treatment actually delivered. Subjects were followed at one week, one month, and six months.
Detailed description
This trial was designed as a prospective, multi-center, randomized clinical trial of the FDA-cleared Vari-Lase Bright Tip Fiber compared to commercially available standard bare-tip laser fiber (control) to demonstrate the safety and effectiveness of laser ablation for the treatment of varicose veins associated with reflux within the great saphenous vein (GSV) and to provide additional data concerning patient satisfaction. Subjects were pre-screened utilizing standard of care data (including documented evidence of reflux within the GSV) for the specified inclusion/exclusion criteria to ensure that they were eligible for treatment in the investigation. Prior to laser treatment and after signing an informed consent form, study eligibility assessments were completed including physical assessment of target limb(s), duplex ultrasound of GSV segment(s) targeted for treatment, symptom assessment, medical history, and digital photos of targeted limbs. Upon enrollment, targeted limbs were randomized at a 1:1 ratio to receive the Vari-lase Bright Tip Fiber or the control treatment. If the subject required treatment of two limbs, the first limb was randomized and the second limb was assigned the other treatment (the opposite treatment of the other limb). Immediately post procedure, subjects were assessed for adverse events and a physical assessment of the treated limb(s) was performed. Subjects were also asked to complete a subject pain and satisfaction questionnaire. Subjects were followed at one week, one month, and six months. Follow-up included a physical assessment of treated limb(s), symptom assessment, adverse event assessment, and completion of a subject pain and satisfaction questionnaire. Additionally, a duplex ultrasound assessment was conducted at one week and six months and digital photos were taken of the treated vein segment(s) at one week and one month. The data was analyzed by treated limb (versus treated subject). All study data were analyzed under the principles of intent-to-treat, in which data are analyzed according to the assigned randomized group regardless of the treatment actually delivered.
Interventions
DEVICEBare Tip Laser Fiber
Endovenous laser ablation treatment for varicose veins in a section of the Greater Saphenous Vein (GSV) using a laser fiber readily available on the market with a bare tip on the end. Treatment performed on one leg.
DEVICEBright Tip Laser Fiber
Endovenous laser ablation treatment for varicose veins in a section of the Greater Saphenous Vein (GSV) using a laser fiber with a fitted ceramic tip on the end. Treatment performed on one leg.
Sponsors
Vascular Solutions LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is 18 years of age or older 2. Subjects with primary varicose veins resultant of GSV reflux documented on duplex ultrasound 3. Subjects that will be undergoing endovenous laser ablation treatment of varicose veins 4. Subjects treatment includes the Greater Saphenous Vein 5. If bilateral, subject is willing and able to undergo treatment of both legs within two weeks. 6. Subjects who are willing and able to comply with the requirements of the study protocol 7. Subjects who are willing and able to provide informed consent
Exclusion criteria
1. Subjects with severe peripheral vascular disease (PVD) as evidenced by an ankle-brachial index of \< 0.5 2. Subjects who are unable to ambulate at baseline 3. Subjects with thrombosis in the vein segment(s) to be treated 4. Subjects that have had prior vein treatment 5. Subjects who are known or suspected to be pregnant or lactating 6. Subjects that are concurrently participating in an investigational study that may confound the treatment or outcomes of the present study 7. Subjects with an active or systemic infection 8. Anatomic variants- duplication of the GSV, presence of incompetent accessory veins of the GSV 9. Subjects who are scheduled to have a bilateral treatment, where one limb is to be enrolled in this study and the second limb that is not treated as part of this study, is treated within two months of the procedure for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Limbs With a Continued Absence of Flow Within the Treated Vein Segment Over 6 Months. | 6 Months | The absence of flow was evaluated in each treated limb and determined by ultrasound (duplex or Doppler) interrogation. |
| Number of Limbs With a Device-related Serious Adverse Event Reported Over 6 Months. | 6 Months | Each treated limb was clinically evaluated for the presence of a device-related serious adverse event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change of Subject Symptoms in Treated Limb From Post-procedure to 6 Months Using Patient Visual Analog Scale (VAS) Pain Scores. | 6 Months | Each subject completed a questionnaire to rate his/her pain. The scale is from 0-10 (0=no pain and 10=worst pain imaginable). Each treated limb was scored by the patient post-procedure and at 6 months to determine the improvement after treatment at the 6-month time point. |
| Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Clinical Severity Score (VCSS). | 6 Months | VCSS is a physician's evaluation of 10 pre-determined clinical signs or attributes of venous disease (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, active ulcer duration, active ulcer diameter and compression therapy). Each attribute receives a score from 0-3 (0=absent and 3=severe). The best total overall score is 0 (all ten attributes are absent) and the worse overall score is 30 (all ten attributes are severe). Each treated limb was evaluated and scored at baseline and at 6 months. |
| Number of Limbs With a Device-related Non-serious Adverse Event Reported Over 6 Months. | 6 Months | Each treated limb was clinically evaluated for the presence of a device-related non-serious adverse event. |
| Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months. | 6 months | Each subject completed a questionnaire to rate their satisfaction with the laser treatment. The score was reported as excellent, good, fair or poor. The best score of excellent was defined as I am very satisfied with the laser treatment and the worse score of poor was defined as I am not satisfied with the laser treatment. Each treated limb was scored by the patient at 6 months to determine the percent satisfaction at the 6-month time point. |
| Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Disability Score (VDS). | 6 Months | VDS is a physician's evaluation of a patient's ability to work an eight-hour day with or without a support device (i.e., compressive therapy, limb elevation). The patient is scored on a scale of 0-3 (0=asymptomatic and 3=unable to carry out usual activities (patients activities before the onset of disability due to venous disease) even with compression and/or limb elevation). The score represents the degree of disability caused by the venous disease with the best score being 0 and the worse score being 3. Each treated limb was evaluated and scored at baseline and at 6 months. |
Countries
United States
Participant flow
Recruitment details
Subjects who had a planned endovenous laser ablation treatment for varicose veins that included treatment of the Greater Saphenous Vein (GSV) were recruited from medical clinics.
Pre-assignment details
93 subjects enrolled, 3 subjects were not randomized because they withdrew consent prior to receiving study procedure; 90 subjects randomized and 110 limbs were assigned treatment.
Participants by arm
| Arm | Count |
|---|---|
| Bright Tip Laser Fiber Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. | 55 |
| Standard Bare Tip Laser Fiber Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. | 55 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 12 | 4 |
Baseline characteristics
| Characteristic | Bright Tip Laser Fiber | Standard Bare Tip Laser Fiber | Total |
|---|---|---|---|
| Age, Continuous | 54.4 years STANDARD_DEVIATION 12.7 | 53.8 years STANDARD_DEVIATION 14.1 | 54.1 years STANDARD_DEVIATION 13.5 |
| Region of Enrollment United States | 55 Limbs | 55 Limbs | 110 Limbs |
| Sex: Female, Male Female | 40 Participants | 44 Participants | 84 Participants |
| Sex: Female, Male Male | 15 Participants | 11 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 54 | 2 / 52 |
| serious Total, serious adverse events | 0 / 54 | 1 / 52 |
Outcome results
Primary
Number of Limbs With a Continued Absence of Flow Within the Treated Vein Segment Over 6 Months.
The absence of flow was evaluated in each treated limb and determined by ultrasound (duplex or Doppler) interrogation.
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bright Tip Laser Fiber | Number of Limbs With a Continued Absence of Flow Within the Treated Vein Segment Over 6 Months. | 36 Limbs |
| Standard Bare Tip Laser Fiber | Number of Limbs With a Continued Absence of Flow Within the Treated Vein Segment Over 6 Months. | 36 Limbs |
Primary
Number of Limbs With a Device-related Serious Adverse Event Reported Over 6 Months.
Each treated limb was clinically evaluated for the presence of a device-related serious adverse event.
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bright Tip Laser Fiber | Number of Limbs With a Device-related Serious Adverse Event Reported Over 6 Months. | 0 Limbs |
| Standard Bare Tip Laser Fiber | Number of Limbs With a Device-related Serious Adverse Event Reported Over 6 Months. | 0 Limbs |
Secondary
Number of Limbs With a Device-related Non-serious Adverse Event Reported Over 6 Months.
Each treated limb was clinically evaluated for the presence of a device-related non-serious adverse event.
Time frame: 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bright Tip Laser Fiber | Number of Limbs With a Device-related Non-serious Adverse Event Reported Over 6 Months. | 2 Limbs |
| Standard Bare Tip Laser Fiber | Number of Limbs With a Device-related Non-serious Adverse Event Reported Over 6 Months. | 1 Limbs |
Secondary
Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months.
Each subject completed a questionnaire to rate their satisfaction with the laser treatment. The score was reported as excellent, good, fair or poor. The best score of excellent was defined as I am very satisfied with the laser treatment and the worse score of poor was defined as I am not satisfied with the laser treatment. Each treated limb was scored by the patient at 6 months to determine the percent satisfaction at the 6-month time point.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bright Tip Laser Fiber | Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months. | Excellent Patient Satisfaction Score | 72.5 Percentage of participants |
| Bright Tip Laser Fiber | Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months. | Good Patient Satisfaction Score | 15.0 Percentage of participants |
| Bright Tip Laser Fiber | Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months. | Fair Patient Satisfaction Score | 7.5 Percentage of participants |
| Bright Tip Laser Fiber | Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months. | Poor Patient Satisfaction Score | 5.0 Percentage of participants |
| Standard Bare Tip Laser Fiber | Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months. | Poor Patient Satisfaction Score | 2.7 Percentage of participants |
| Standard Bare Tip Laser Fiber | Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months. | Excellent Patient Satisfaction Score | 64.9 Percentage of participants |
| Standard Bare Tip Laser Fiber | Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months. | Fair Patient Satisfaction Score | 2.7 Percentage of participants |
| Standard Bare Tip Laser Fiber | Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months. | Good Patient Satisfaction Score | 29.7 Percentage of participants |
Secondary
Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Clinical Severity Score (VCSS).
VCSS is a physician's evaluation of 10 pre-determined clinical signs or attributes of venous disease (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, active ulcer duration, active ulcer diameter and compression therapy). Each attribute receives a score from 0-3 (0=absent and 3=severe). The best total overall score is 0 (all ten attributes are absent) and the worse overall score is 30 (all ten attributes are severe). Each treated limb was evaluated and scored at baseline and at 6 months.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bright Tip Laser Fiber | Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Clinical Severity Score (VCSS). | -64.1 percentage change | Standard Deviation 22.5 |
| Standard Bare Tip Laser Fiber | Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Clinical Severity Score (VCSS). | -59.4 percentage change | Standard Deviation 34.8 |
Secondary
Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Disability Score (VDS).
VDS is a physician's evaluation of a patient's ability to work an eight-hour day with or without a support device (i.e., compressive therapy, limb elevation). The patient is scored on a scale of 0-3 (0=asymptomatic and 3=unable to carry out usual activities (patients activities before the onset of disability due to venous disease) even with compression and/or limb elevation). The score represents the degree of disability caused by the venous disease with the best score being 0 and the worse score being 3. Each treated limb was evaluated and scored at baseline and at 6 months.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bright Tip Laser Fiber | Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Disability Score (VDS). | -39.3 percentage of change | Standard Deviation 25.5 |
| Standard Bare Tip Laser Fiber | Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Disability Score (VDS). | -47.1 percentage of change | Standard Deviation 19.2 |
Secondary
Percent Change of Subject Symptoms in Treated Limb From Post-procedure to 6 Months Using Patient Visual Analog Scale (VAS) Pain Scores.
Each subject completed a questionnaire to rate his/her pain. The scale is from 0-10 (0=no pain and 10=worst pain imaginable). Each treated limb was scored by the patient post-procedure and at 6 months to determine the improvement after treatment at the 6-month time point.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bright Tip Laser Fiber | Percent Change of Subject Symptoms in Treated Limb From Post-procedure to 6 Months Using Patient Visual Analog Scale (VAS) Pain Scores. | -35.8 percentage of change | Standard Deviation 54.8 |
| Standard Bare Tip Laser Fiber | Percent Change of Subject Symptoms in Treated Limb From Post-procedure to 6 Months Using Patient Visual Analog Scale (VAS) Pain Scores. | -44.9 percentage of change | Standard Deviation 44.8 |