Cardiovascular Abnormalities Clinical Trial
Official title:
Clinical Study on Efficacy and Safety of the mTor Rapamycin Inhibitor Found in the Complex Vascular Malformations
The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of
rapamycin (mTor) pathway plays a role on the development and the lymphatic-vascular
organisations.
The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.
The complex vascular malformations induce chronical pains and organic dysfunctions causing
significant morbidity and mortality. Therefore, the investigators need to establish
guidelines in order to treat these pathologies. Standard treatments such as surgery or
interventional radiology are of limited efficacy and related to a high level of recurrences
as well as complications. Recent preclinical studies have shown the important role of the
PI3Kinase/AKT/mTor pathway on the development and the lymphatic-vascular organisations
suggesting an appealing therapeutic target to treat patients with complex vascular
malformations.
The aim of this clinical study is to prospectively evaluate the efficacy and the safety of
the Rapamycin, an mTOR inhibitor, to treat children and adults with microcystic lymphatic
malformations, general lymphatics abnormalities (GLA) or complex vascular malformations for
which conventional therapies as surgery or sclerotherapy are ineffective or associated with
high risk of important complications.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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