The BRILLIANT Study

Stopped early · Not applicable

Conditions studied: Varicose Veins

In brief

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.

Key facts

Study ID

NCT00618514

Run by

Vascular Solutions LLC

People needed

93

Starts

2008-06-01

Expected to finish

2009-08-01

Last updated by the study team

2015-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is 18 years of age or older
• Subjects with primary varicose veins resultant of GSV reflux documented on duplex ultrasound
• Subjects that will be undergoing endovenous laser ablation treatment of varicose veins
• Subjects treatment includes the Greater Saphenous Vein
• If bilateral, subject is willing and able to undergo treatment of both legs within two weeks.
• Subjects who are willing and able to comply with the requirements of the study protocol
• Subjects who are willing and able to provide informed consent

You may not qualify if…

• Subjects with severe peripheral vascular disease (PVD) as evidenced by an ankle-brachial index of < 0.5
• Subjects who are unable to ambulate at baseline
• Subjects with thrombosis in the vein segment(s) to be treated
• Subjects that have had prior vein treatment
• Subjects who are known or suspected to be pregnant or lactating
• Subjects that are concurrently participating in an investigational study that may confound the treatment or outcomes of the present study
• Subjects with an active or systemic infection
• Anatomic variants- duplication of the GSV, presence of incompetent accessory veins of the GSV
• 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

Where it is running

• Southeast Vein and Laser — Dothan, Alabama, United States
• Morrision Vein Institute — Scottsdale, Arizona, United States
• HealthwoRx — Hollywood, Florida, United States
• Mackay Center for Vein Treatment and Laser Therapy — Palm Harbor, Florida, United States
• Comprehensive Wound Care — Kinston, North Carolina, United States
• Pottstown Memorial Hospital — Pottstown, Pennsylvania, United States
• The Vein Center of Virginia — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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