Clinical trial NCT00618514: The BRILLIANT Study
Official title: Comparative Evaluation of the FDA-Cleared Bright Tip Laser Fiber Versus Commercially Available Bare Laser Fiber (the Control) in the Treatment of Reflux in the Greater Saphenous Vein (GSV) Using Endovenous Laser Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Varicose Veins
Keywords: Varicose Veins
Laser Ablation
Laser Wire Fibers
Lead sponsor: Vascular Solutions LLC
Sponsor class: INDUSTRY
First posted: 2008-02-20
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Limbs With a Continued Absence of Flow Within the Treated Vein Segment Over 6 Months.
timeFrame: 6 Months
measure: Number of Limbs With a Device-related Serious Adverse Event Reported Over 6 Months.
timeFrame: 6 Months
Secondary outcomes:
measure: Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Clinical Severity Score (VCSS).
timeFrame: 6 Months
measure: Percent Change of Subject Symptoms in Treated Limb From Baseline to 6 Months Using Venous Disability Score (VDS).
timeFrame: 6 Months
measure: Percent Change of Subject Symptoms in Treated Limb From Post-procedure to 6 Months Using Patient Visual Analog Scale (VAS) Pain Scores.
timeFrame: 6 Months
measure: Percentage of Subjects Reporting an Excellent Satisfaction Score at 6 Months.
timeFrame: 6 months
measure: Number of Limbs With a Device-related Non-serious Adverse Event Reported Over 6 Months.
timeFrame: 6 Months
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Southeast Vein and Laser
state: Alabama
city: Scottsdale
country: United States
facility: Morrision Vein Institute
state: Arizona
city: Hollywood
country: United States
facility: HealthwoRx
state: Florida
city: Palm Harbor
country: United States
facility: Mackay Center for Vein Treatment and Laser Therapy
state: Florida
city: Kinston
country: United States
facility: Comprehensive Wound Care
state: North Carolina
city: Pottstown
country: United States
facility: Pottstown Memorial Hospital
state: Pennsylvania
city: Virginia Beach
country: United States
facility: The Vein Center of Virginia
state: Virginia
Study officials:
affiliation: Image Guided Surgery Associates
name: Robert Worthington-Kirsch, MD
role: PRINCIPAL_INVESTIGATOR
References: