The ClariVein device using 2% and 3% liquid Polidocanol for the treatment of great saphenous vein incompetence

The standard treatment for an incompetent great saphenous vein (GSV) is
surgical stripping of the GSV combined with high ligation of the saphenofemoral
junction. The prevalence of venous insufficiency in Europe and the United
States is between 5 and 15 percent in men and between 15 and 30 percent in
women. The severity of the disease varies from cosmetics objections to chronic
venous insufficiency leading in 1% to ulcer formation with bad healing
tendencies. The treatment of trunk varicosity can be complemented with
sclero-compression therapy or ambulant phlebectomy according to Muller for the
remaining varicosis. In recent years, numerous minimal invasive therapies have
been developed to treat GSV incompetence. These methods include
sclero-compression, foam sclero-compression, laser and radio frequent
ablation-therapy. These methods give better outcomes in terms of pain and
return to normal activities, while the closure rate remains high compared to
stripping of the vein. The surgical method is mostly performed under general
anesthesia and the newer endogenous thermal methods under tumescent anesthesia.
Perceived advantages over traditional surgery include fewer complications,
minimal post procedural pain and faster recovery times. The use of minimal
invasive methods increases steadily. ClariVein® is a new device for the
treatment of GSV insufficiency. The technique uses a combination of chemical
and mechanical components to assure long term closure of the insufficient GSV
without needing any anesthesia.

Our study tries to identify the ideal sclerosant dosage for the ClariVein®
system in order to occlude the GSV permanently. By choosing the lowest dose
with the same anatomical success rate, we achieve a safe treatment which also
gives us the possibility to increase the maximum treatment length of the
incompetent GSV. Our hypothesis is that there is no difference in outcome
between patients having their incompetent GSV treated with ClariVein therapy
using Polidocanol 2%, 3% liquid.

This prospective randomized controlled trial will be conducted in the
Maastricht university hospital (MUMC+) and other clinics specialized in
phlebology. All eight hospitals are located in the Netherlands. The MUMC+ will
provide the trial coordinator, who manages the inclusion and randomization of
patients in the MUMC+ and in each other center a dedicated coordinator will be
appointed in the other clinics. Our research team will be completed with a
project leader and an independent physician. 400 patients will be included in
the study and divided equally over 2 groups. The patients will be randomized
amongst the next groups: Group 1: ClariVein® simultaneous with 2% Polidocanol,
Group 2: ClariVein® simultaneous with 3% Polidocanol. In each group 30cm of
incompetent GSV will be treated with 5mL sclerosant. The treatment is limited
due to the toxicity of Polidocanol which should not exceed more than 2mg per kg
body weight per day.All patients are referred by the general practitioner for
their symptoms of venous incompetence, e.g. varicose veins. At the first visit
the patient is assessed for inclusion criteria by the physician. If the patient
meets the inclusion criteria, they will be informed about the study and they
are given the information brochure. The patient is explicitly told that they
are able to withdraw from the study at any time for any reason without any
explanation and they will be guaranteed of the best medical care available.
Computerized block randomization for allocation of treatment group which is
stratified for centre, will take place after all inclusion and exclusion
criteria have been verified and informed consent has been obtained. The result
of the randomization is not mentioned to the patient to ensure blinding of the
study. After randomization the patient will be scheduled for the treatment
within 6 weeks.

ClariVein liquid Polidocanol (2%,3%) procedure:
The patient will be examined by ultrasound to identify the GSV at the knee
level. This will be done while the patient is standing. After the GSV is
identified the patient will take place on the operating table and a Venflon
needle will be inserted at knee level and a sheath will be introduced to ensure
access for the ClariVein® system. The ball tip of ClariVein® system is placed
2cm distal to the saphenofemoral junction, measured from the hard shoulder of
the saphenofemoral junction. The wire will be activated at the setting of 3500
rpm and after 3 seconds it will be moved distally at a steady pace of 1.0 -
2.0mm / second, 6 seconds per centimeter. With the rotating wire applying
mechanical damage to the veinwall 5 mL Polidocanol is injected into the GSV.
After 30 cm of the GSV is treated the system is removed from the vein.

Duplex ultrasonography will be performed after the procedure to visualize and
quantify the spasm of the obliterated GSV segment and confirm patency of the
deep venous system. Directly after the procedure a class 2 thigh stocking is
applied to the leg for 48 hours and 2 weeks during daytime. There is no need
for any form of anesthesia or analgesia during the procedure. Patients can
resume their daily activities immediately. Because of the learning curve the
physician operating the device has to acknowledge the performance of at least
10 procedures with ClariVein®, before treating patients in the study group.
Training will be provided by Vascular Insights who will assist and train the
physician for the first 10 ClariVein® treatments.

A possible drawback to this research is the extra time that is needed for
completing questionnaires.