Efficacy/Safety of Ecraprost in Lipid Emulsion for Treatment of Critical Leg Ischemia Due to Peripheral Arterial Disease
Peripheral Vascular Disease
About this trial
This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring Ecraprost in lipid emulsion, CLI, peripheral, vascular, amputation, Angioplasty, by-pass, Critical Limb Ischemia due to peripheral arterial disease
Eligibility Criteria
Inclusion Criteria: Critical leg ischemia (CLI) defined as distal extremity pain at rest, or peripheral ischemic ulcer(s), with severe hemodynamic impairment as diagnosed by ankle systolic pressure, toe systolic pressure or TcPO2 Subjects will already be scheduled to receive a revascularization procedure (e.g., by-pass graft, endovascular procedure, etc.) involving a distal target artery below the knee joint (e.g., below the knee joint popliteal, anterior/posterior tibial, peroneal, plantar, pedal, etc.) as part of their normal standard of care. Exclusion Criteria: Subjects with a previous major amputation (at or above ankle) Subjects with end stage renal disease (ESRD) defined as significant renal dysfunction evidenced by estimated creatinine clearance of < 20 cc/min, or receiving chronic hemodialysis therapy.