This trial is designed as a prospective, non randomized, single center clinical trial to
determine the safety and efficacy of laser ablation of incompetent perforator veins.
Within this clinical evaluation, fifty (50) limbs will be treated with Vari-Lase ®. A
duplex ultrasound will verify the presence or absence of incompetent perforator veins (IPV).
In addition, the number, diameter and location of the IPVs will be determined. Limbs with
IPVs which measure greater than or equal to 3mm in diameter and are located superior to the
foot and distal ankle will be considered for entry into the study.
This is a non randomized, single center clinical investigation, evaluating a total of fifty
(50) limbs for the treatment of venous stasis ulcerations using the Vari-Lase laser.
Subjects can be pre-screened utilizing standard of care data for the specified
inclusion/exclusion criteria to ensure that they are eligible for treatment in the
investigation. All subjects will have a mapping duplex ultrasound study in an Intersocietal
Commission for the Accreditation of Vascular Laboratories (ICAVL) approved vascular
laboratory. The ultrasound will verify the presence or absence of IPVs. The number,
diameter, and location of the IPVs will be mapped. 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 satisfying all of the inclusion/exclusion
criteria the subject will be accepted into the study.
After enrollment, the investigator will document the CEAP class, venous clinical severity
score (VCSS), and venous disability score (VDS) in the subject's chart/medical record/source
documentation for later transcription on the appropriate case report form. Digital
photographs will be taken of the limb to be treated prior to treatment with the subject
standing, following a standardized photography regimen.
All enrolled study participants will have a limb treated with the Vari-Lase laser
manufactured by VSI. Subject preparation will be the same as for standard greater saphenous
vein (GSV) or short saphenous vein, endovenous laser treatment. The initial technical
success or failure of the procedure will be noted for each IPV and the pre-diameter of the
IPV recorded. Multiple perforators may be treated in a single patient, as well as bilateral
Follow-up duplex exams will be conducted within the first week of treatment and at 6 months.
Follow-up duplex will verify patency vs. closure of IPV, and presence or absence of deep
vein thrombosis (DVT) associated with that IPV. The goal is to prove successful closure of
the treated IPVs veins as demonstrated by the duplex ultrasound at 6 weeks and show
maintained closure of IPVs at 6 months.
Clinical examinations will occur at 2 weeks with an Associated Research Nurse Practitioner,
at 6 weeks with the Medical Doctor, and at 6 months with either the Nurse Practitioner or
Medical Doctor. At the 6 week visit, photos will be taken of the limb treated and there
will be a reclassification of CEAP class, VDS, and VCSS.
1. The subject is 18 years of age or older.
2. The subject has the presence of incompetent perforator veins measuring > 3 mm in
diameter resultant of reflux documented on duplex ultrasound.
3. The subject has a CEAP classification of 3, 4, 5 or 6.
4. The subject has incompetent perforator veins that are superior to the foot and distal
5. The subject is willing and able to provide appropriate informed consent.
6. The subject is willing and able to comply with the requirements of the study
protocol, including the predefined follow-up evaluations.
1. The subject has a history of significant arterial disease.
2. The subject is known to be, or suspected to be, pregnant (verified in a manner
consistent with institution's standard of care), or is lactating.
3. The subject has an Ankle Brachial Index (ABI) of < 0.5
4. The subject has occlusive thrombosis in the vein segment to be treated.
5. The subject has acute deep vein thrombosis.
6. The subject has an active or systemic infection.
7. The subject is or was enrolled in another investigational device or drug trial that
may interfere with the results of this trial.