Primary Insufficiency of the GSV With a Diameter >/= 12 mm, Antero-lateral Branches, or Below the Knee
Condition: Varicose Veins; Dilated Veins
MeSH terms: Varicose Veins
Study type: Observational [Patient Registry]

Summary: 
      The goal of this registry study is to provide insight in the safety and efficacy of treatment
      with MOCA for primary insufficiency of the GSV with a diameter >/=12mm, insufficient
      antero-lateral branches and insufficiency of the GSV below the knee.
    

Detailed description: 
      Varicose veins are a common problem in the World. From epidemiological studies we know that a
      quarter of the adult population suffers from some sort of varicose veins. Women suffer two to
      three times more often from varicose veins than men. The occurrence of varicose veins
      increase with increasing age and is one of the top ten complaints for which patients visit
      their general practitioner. De main risk factors for developing varicose veins are enduring
      standing or sitting, pregnancy, female gender and age. Symptoms are divers and vary from
      cosmetic complaints to difficult to treat venous ulcers.

      Last few years endovenous techniques have been developed for the primary treatment of
      insufficient varicose veins. Radiofrequent ablation (RFA)is, besides endovenous laser
      ablation (EVLA), an accepted technique and is frequently applied in clinical practice. This
      technique, that uses heat, has the important advantage that the treatment can be performed
      using a slight local anaesthesia. Besides that, RFA causes less hematoma, pain, a superior
      cosmetic and patient are able to restart daily activities sooner than compared to the
      classical surgical treatment. Because RFA using heat technology, damage can occur in the
      surrounding tissues. That is the reason for using tumescent anaesthesia, for which multiple
      injections are needed. A column of liquid is placed surrounding the vein. Many patients
      experience this column as inconvenient and despite this form of anaesthesia part of the
      treated patient population experiences pain after the treatment that can last up to weeks.

      A newer endovenous technique is mechano-chemical ablation (MOCA) has been developed, using
      the ClariVein system. This technique uses intentional mechanical damage to the endothelium of
      the vene by means of a rotating catheter. At the same time a sclerosans is injected, and as a
      result the vene occludes. So this technique does not use heat technology. Tumescent
      anaesthesia is therefore not needed and complications related to techniques using heat (RFA
      and EVLA) such as burning, pain, hematoma, indurations, and paresthesia could be reduced or
      even be prevented.

      MOCA proved to be a safe and effective alternative treatment for both insufficient great
      saphenous veins (GSV) and small saphenous veins (SSV). Especially for the treatment of the
      below-knee GSV and the treatment of superficial branches (such as the antero-lateral
      branches), there is a risk for damaging nerves that are in the close proximity of these
      veins.

      In a series of 50 patients treated with EVLA for insufficient GSV above the knee, a technical
      success of 100% was reported after a median follow-up of 7 months, but this was accompanied
      by nerve damage in 8%. A recent study evaluating MOCA for the treatment of SSV reported an
      anatomical success of 96% without any nerve damage or other major complications. Therefore,
      MOCA could be an alternative for the treatment of various insufficient varicose vein segments
      without causing nerve damage.

      The choice of treatment for patients with both above and below knee GSV insufficiency is
      nowadays only endovenous ablation of the above-knee segment. However, Theivacumar and
      co-workers recently showed that in these patients there is a significant residual reflux in
      approximately 41% of treated legs. These patients clearly showed less clinical improvement
      and approximately 90% of these patients needed additional treatment.

      Up to now it is unknown whether treatment with MOCA can yield comparable results when used to
      treat insufficient GSV with diameters >= 12 mm, insufficient antero-lateral branches and
      insufficient GSV below the knee. The goal of this registry study is to provide insight in the
      safety and efficacy of treatment of the above described insufficient varicose vein segments.
    

Intervention name(s): Mechano-chemical ablation
Intervention type(s): Procedure
Intervention description(s): Treatment with mechano-chemical ablation
Other intervention name(s): MOCA
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with primary insufficiency of the GSV with diameters >/=12 m m, insufficient
        antero-lateral branches or below-knee GSV insufficiency
      
Keywords: Mechano-chemical ablation; Treatment large varicose veins; Below-knee and branches; Endovenous