Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt
Condition: Varicose Veins
MeSH terms: Varicose Veins
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety of the Varisolve® procedure in patients
      with right-to-left cardiac shunt (a defect in the heart).
    

Detailed description: 
      Varicose veins are extremely common, affecting up to 25% of the western adult population.
      While in their early stages they are little more than a sometimes-painful aesthetic problem,
      progression is inevitable and some will progress to more severe and largely irreversible
      problems of chronic venous insufficiency (CVI) and, finally, venous leg ulcer. At present, no
      system has been proven to identify those that will progress and while varicose veins are not
      the only cause of CVI, in approximately 50% of patients with leg ulcers, superficial varicose
      veins are the only causal factor identified. The cost of management of simple varicose veins
      is relatively small in comparison with the long-term management of CVI and leg ulcers. Many
      patients progress to develop leg ulcers without having received primary treatment for their
      varicose veins.

      The current management of major varicose veins includes maintenance by compression stockings,
      injection sclerotherapy with liquid sclerosants, and superficial vein surgery. The
      disadvantages to surgery include the use of general anesthesia, incisions resulting in
      possible scars, a painful recovery period with significant functional down time and
      historically high rates of recurrence. Sclerotherapy has been performed since 1851 with the
      advent of hypodermic needles. The two surfactant sclerosants most widely used are sodium
      tetradecyl sulphate (STS, STD®, Sotradecol or Fibro-vein) and polidocanol (Macrogol 400 Ph
      Eur, Aethoxyskerol®). Sotradecol is the only FDA-approved sclerosant. With the advent of
      duplex ultrasound scanning, the technique of echo-guided sclerotherapy has widened the
      possibilities for sclerotherapy of large veins but the liquid sclerosants available are
      rapidly deactivated and diluted by blood frequently resulting in unsatisfactory outcomes.
      Because the microfoam delivers sclerosant more efficiently to the venous endothelium, it is
      believed that lower concentrations of polidocanol (Varisolve)can be used when compared with
      liquid sclerosant. BTG International Ltd is developing sclerosant microfoam technology based
      on polidocanol (PD)(Varisolve) into a pharmaceutical product.

      The presence of bubbles in the heart has been a concern as bubbles may pass from the right
      heart to the left through a patent foramen ovale (PFO) or other right-to-left shunt. Once in
      the systemic circulation, some bubbles inevitably pass into the cerebral circulation where
      their theoretical potential for causing damage due to occlusion of vessels is recognized yet
      ill defined.

      Therefore this study is to determine whether patients with bubbles detected in the middle
      cerebral artery (MCA) during the Varisolve® procedure experience any sub-clinical,
      safety-related events such as abnormalities on brain MRI, neurological examination, cardiac
      markers or other symptoms or signs.
    

Intervention name(s): Polidocanol (1%) Microfoam (Varisolve); Endovenous Microfoam Occlusion
Intervention type(s): Drug; Procedure
Intervention description(s): Varisolve polidocanol 1% microfoam, maximum of 20ml injected into affected great saphenous vein.; Varisolve® polidocanol microfoam injection under duplex guidance to fill proximal and distal great saphenous vein and varicose tributaries.
Intervention MeSH terms: Polidocanol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PFO; Patent Foramen Ovale; Right-to-Left Shunt; Sclerotherapy