Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt (MRI)
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).
Drug: Polidocanol (1%) Microfoam (Varisolve)
Procedure: Endovenous Microfoam Occlusion
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Multicenter Safety Study of the Varisolve® Procedure for the Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt|
- Patients With Circulating MCA Bubbles Present on MRI Who Had Signficant Clinical or Neurological Effects [ Time Frame: 28 day followup ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Study Completion Date:||August 2009|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Polidocanol (1%) Microfoam (Varisolve)
Drug: Polidocanol (1%) Microfoam (Varisolve)
Varisolve polidocanol 1% microfoam, maximum of 20ml injected into affected great saphenous vein.Procedure: Endovenous Microfoam Occlusion
Varisolve® polidocanol microfoam injection under duplex guidance to fill proximal and distal great saphenous vein and varicose tributaries.
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.
|United States, California|
|Los Angeles, California, United States, 90033|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Texas|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Bellevue, Washington, United States, 98004|
|Study Director:||Janet Rush, MD||BTG International Inc.|