saline placebo (Mercator MedSystems)

Saline placebo is the control agent used in clinical trials conducted by Mercator MedSystems, Inc., specifically within the TANGO trial series (including TANGO and TANGO-3). In these studies, the saline is administered into the perivascular or adventitial tissue of below-the-knee arteries using the Bullfrog Micro-Infusion Device. This procedure is performed following revascularization (angioplasty or atherectomy) in patients with symptomatic peripheral artery disease (PAD) or critical limb ischemia (CLI), typically categorized as Rutherford class 3-5. The saline placebo, which often includes a contrast medium for visualization, serves as a pharmacologically inert comparator to evaluate the efficacy and safety of adventitial temsirolimus delivery in reducing neointimal hyperplasia and restenosis.

Other names

saline controlplacebo