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This trial is looking at a new treatment called the Efemoral Vascular Scaffold System (EVSS), a tiny dissolvable scaffold coated with medication that helps keep blood flowing in narrowed or blocked leg arteries. VSS is designed to support the artery while it heals and then gradually dissolve, leaving the vessel free to move naturally. This may improve circulation, reduce symptoms like leg pain when walking, and support long-term artery health.

The purpose of this study is to test the ability of an experimental drug (study drug) named VMX-C001 to bypass the effect of a medication that you are currently taking known as a FXa direct oral anticoagulant (FXa DOAC). FXa DOACs are anticoagulant (blood-thinning) drugs that reduce the risk of blood clots but increase the risk of bleeding. Therefore, in certain situations, patients taking FXa DOACs need to receive other drugs that can restore the ability of their blood to clot (coagulation), as in the cases of serious bleeding or when requiring urgent surgery or another procedure that is associated with a high risk of bleeding. Because you may have taken an FXa DOAC within the last 15 hours, it is usual for your medical team to want to restore coagulation during the surgery to prevent excessive bleeding. The main purpose of this research study is to: Evaluate the safety of the study drug, VMX-C001; Determine the efficacy of VMX-C001 (how well the drug works); Assess the pharmacokinetics (PK) of VMX-C001 (PK; how the drug is processed through your body); Assess the immunogenicity of VMX-C001 (how the drug works on your immune system).