The BRILLIANT Study - Full Text View

Sponsored by:	Vascular Solutions, Inc
Information provided by:	Vascular Solutions, Inc
ClinicalTrials.gov Identifier:	NCT00618514

Purpose

This trial is designed as a prospective, multi-center, randomized clinical trial to evaluate the safety and effectiveness of the Bright Tip Fiber as compared to standard bare laser fibers for the treatment of varicose veins associated with reflux within the GSV.

Within this evaluation, study subjects will be randomized to one of two (2) treatment groups. Fifty (50) percent of the study limbs will be randomized to the Bright Tip Fiber group, while fifty (50) percent will be randomized to the bare fiber group, thus utilizing a 1:1 randomization ratio. All study data will be analyzed under the principles of intent-to-treat, in which data will be analyzed according to the assigned randomized group regardless of the treatment actually delivered.

Subject follow-up will be within 1 week of procedure, 1 month, and 6 months post procedure at the vascular clinic, followed by a 12 month telephone assessment.

Condition	Intervention
Varicose Veins	Device: Bright Tip Laser Fiber Device: Bare Tip laser fiber

MedlinePlus related topics: Varicose Veins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Official Title:	Comparative Evaluation of the Bright Tip Laser Fiber Versus Bare Laser Fiber in the Treatment of Reflux in the Greater Saphenous Vein (GSV) Using Endovenous Laser Therapy

Further study details as provided by Vascular Solutions, Inc:

Primary Outcome Measures:

The primary objective of this trial is to demonstrate the clinical effectiveness (as determined by the absence of flow within the treated vein segment) of the Bright Tip fiber as compared to standard bare fibers. [ Time Frame: One Year ] [ Designated as safety issue: No ]
The primary safety objective is to evaluate the incidence rate of device-related Serious Adverse Events (SAEs). [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Effectiveness: Based on the reduction of subject symptoms as seen on the VCSS and VDS. [ Time Frame: One Year ] [ Designated as safety issue: No ]
Subject satisfaction: Based on scoring of the Modified Odom's criteria, post-procedural pain (VAS), and based on post-procedural bruising (Blinded review of digital photos) [ Time Frame: One Year ] [ Designated as safety issue: No ]
Safety: Incidence rate of device-related non-serious adverse events [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	January 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Bright Tip Laser Fiber	Device: Bright Tip Laser Fiber Laser fiber for use in endovenous ablation with a fitted ceramic tip on the end to allow for greater visibility under ultrasound and increased efficiency during procedures
2: Active Comparator Standard bare tip Laser Fiber	Device: Bare Tip laser fiber Bare tip laser fiber readily available on the market

Detailed Description:

This trial is designed as a prospective, multi-center, randomized clinical trial to evaluate the safety and effectiveness of the Bright Tip Fiber as compared to standard bare laser fiber for the treatment of varicose veins associated with reflux within the GSV.

Subjects can be 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 are eligible for treatment in the investigation. If the subject appears to qualify for the investigation, the subject will then be asked to give his/her written informed consent and be enrolled in the investigation.

Upon study enrollment, the subject will be randomized to receive the Bright Tip fiber and/or a standard bare fiber for use during endovenous laser therapy in the following manner:

If the subject has one limb to be treated, he/she will be randomized to receive either the Bright Tip fiber or the standard bare fiber.
If the subject has two limbs to be treated, he/she will be randomized to receive the Bright Tip fiber in one leg and the bare fiber in the other leg.

After enrollment, the subject will undergo endovenous laser therapy, followed by a limited duplex ultrasound of the GSV segment treated if vein diameter or other required data has not been obtained. A physical assessment of the treated limb(s) and an assessment for complications will also be obtained.

All subjects will be required to complete follow-up visits at 1 week, 1 month and 6 months post-procedure for a clinical assessment of the treated segment(s). Assessment of the primary and secondary endpoints will take place at these time points. A telephone follow-up will be conducted at 12 months post procedure in order to supplement the data gathered at six months. Adverse events assessment will be made at each follow-up time point.

From baseline to the final study exam, data pertaining to the investigational objectives will be recorded on the appropriate case report forms at the predetermined study intervals.

Assignment of bruising will be completed by a single blinded rater.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 have provided written informed consent

Exclusion Criteria:

Subjects with severe peripheral vascular disease (PVD) as evidenced by an ankle-brachial index of < 0.5 (If the subject has evidence of PVD then an ABI should be collected. However, if the subject has no signs of PVD then there will be no need to collect an ABI.)
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 including stripping and ligation, radiofrequency ablation, laser ablation, sclerotherapy.
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 GSV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618514

Contacts

Contact: Mike Swierzewski, Clinical Research Associate	763-656-4370	mswierzewski@vascularsolutions.com
Contact: Deborah Neymark, VP, Clinical, Regulatory	763-656-4249	DNeymark@vascularsolutions.com

Locations

United States, Alabama
Southeast Vein and Laser	Recruiting
Dothan, Alabama, United States, 36303
Contact: Darlene Beech 334-678-9494
Principal Investigator: Kenneth Todd, MD
United States, Arizona
Morrision Vein Institute	Recruiting
Scottsdale, Arizona, United States, 85255
Contact: Elaine Johnson 480-860-6455
Contact: Sharon Olbert 480-860-6455
Principal Investigator: Nick Morrison, MD
United States, Florida
HealthwoRx	Recruiting
Hollywood, Florida, United States, 33021
Contact: Heisy Almonte 954-983-8910
Principal Investigator: Yale Cohen, MD
Mackay Center for Vein Treatment and Laser Therapy	Recruiting
Palm Harbor, Florida, United States, 34683
Contact: Jill Lane 727-781-5652
Principal Investigator: Edward Mackay, MD
United States, North Carolina
Comprehensive Wound Care	Recruiting
Kinston, North Carolina, United States, 28501
Contact: Sandra Jackson 252-527-9928
Principal Investigator: Joseph Whitlark, MD
United States, Pennsylvania
Pottstown Memorial Hospital	Recruiting
Pottstown, Pennsylvania, United States, 19464
Contact: Robert Worthington-Kirsch, MD kirsch@igsapc.com
Principal Investigator: Robert Worthington-Kirsch, MD
United States, Utah
Intermountain Vein Center	Not yet recruiting
Provo, Utah, United States, 84604
Contact: Paul Lemon 801-358-5781
Principal Investigator: Carl Black, MD
United States, Virginia
The Vein Center of Virginia	Not yet recruiting
Virginia Beach, Virginia, United States, 23452
Contact: Jan Devlin 757-470-5571
Principal Investigator: F. Noel Parent, MD
Sub-Investigator: Scott McEnroe, MD

Sponsors and Collaborators

Vascular Solutions, Inc

Investigators

Study Director:	Robert Kirsch, MD	Image Guided Surgery Associates
Principal Investigator:	Yale Cohen, MD	HealthwoRx
Principal Investigator:	Nick Morrison, MD	Morrison Vein Institute
Principal Investigator:	Edward Mackay, MD	Mackay Vein Institute
Principal Investigator:	Noel Parent, MD	Vein Center of Virginia
Principal Investigator:	Joseph Whitlark, MD	Comprehensive Wound Care
Principal Investigator:	Carl Black, MD	Intermountain Vein Center
Principal Investigator:	John Regan, MD	Wake Forest University Baptist Medical Center
Principal Investigator:	Kenneth Todd, MD	Southeast Vein and Laser

More Information

Responsible Party:	Vascular Solutions Inc. ( Sue Walgren, Director of Clinical Research )
Study ID Numbers:	0407
Study First Received:	February 6, 2008
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00618514
Health Authority:	United States: Institutional Review Board

Keywords provided by Vascular Solutions, Inc:

Varicose Veins
Laser Ablation
Laser Wire Fibers
Comparison of laser fibers currently available for the treatment of Varicose Veins.

Study placed in the following topic categories:

Varicose Veins
Vascular Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009