Systemic and Local Diffusion of Ethanol After Administration of Ethanol 96% Formulated in a Gel and Ethanol 98% Solution by the Percutaneous Route, in Patients With Congenital Venous Malformations:Pharmacokinetic, Pharmacodynamic and Clinical Study.

Exclusion Criteria

• •Patients under 12 years of age,
• •Pregnant women, nursing mothers and women of childbearing potential with no reliable contraception from more than 2 months,
• •Women of childbearing potential with a positive pregnancy test at baseline,
• •Patients with CVM of non venous predominance,
• •Patients with CVM that are not reachable by the percutaneous route,
• •Patients with extensive superficial skin CVM (i.e. with high risk of skin necrosis),
• •Patients with a test lesion adjacent to major nerves (e.g. facial nerve in the parotid region, intramuscular regions adjacent to major nerves),
• •Patients with facial CVM or bone involvement,
• •Patients with small CVM lesion (\<12 cm3 at MRI),
• •Patients requiring more than 1 ml/Kg body weight (b.w.) in USA or more than 0.5 ml/Kg b.w. in France, or more than 30 mL of absolute ethanol to infuse,
• •Patients with a known allergy to one of the components of the test products,
• •Patients with a suspected allergy to iodinate.ed products,
• •Patients with abnormal clotting parameters (platelets, partial thromboplastin, prothrombin time),
• •Patients with an active inflammatory episode of the test lesion (i.e. acute or subacute swelling of the test lesion),
• •Patients with complex malformations (e.g. Klippel-Trenaunay syndrome, Blue Rubber Bled Nevus syndrome, Muco-cutaneous familial venous malformations, Mafucci's syndrome),
• •Patients in which a surgery, laser therapy or embolosclerotherapy of the test lesion has been performed within the last 12 weeks prior to study entry,
• •Asthmatic patients who require daily medications,
• •Patients with a non treated or non stabilized cardiac disease,
• •Patients with a suspected right-left shunt,
• •Patients with an intercurrent condition or a concomitant treatment which may interfere with a good conduct or the evaluation parameters of the study,
• •Patients who participated in a study within the 12 weeks prior to study entry,
• •Patients or parents who are not able or willing to follow the study instructions,
• •Patients or parents who refuse to give written informed consent.