Safety and Preliminary Efficacy Study of an Anti-inflammatory Therapeutic Antibody in Reducing Restenosis.

Overview

The purpose of this study is to determine if CV-18C3 will reduce the rate of restenosis or the time to restenosis in patients undergoing repeat peripheral artery revascularization versus controls randomized to standard of care.

Restenosis of peripheral artery lesions remains a challenging problem to overcome after percutaneous revascularization of atherosclerotic disease in the femoropopliteal arterial system. Rates of restenosis are as high as 60% after a year. Treatment options include medical therapy, angioplasty, arthrectomy and stent placement. The heterogeneity of disease between patients, variable length of target lesions and presence of unpredictable physical forces requires individualized treatment plans. Vascular response to injury appears to play an important role in the development of restenosis. IL-1α is a potent inflammatory cytokine that plays a central role in vascular inflammation and vascular smooth muscle proliferation--both in acute and chronic injury. CV-18C3 antagonizes the biologic activity of IL-1α and is theorized to prevent the early IL-1α mediated inflammation that leads to vascular smooth muscle hypertrophy and restenosis, as well as the late IL-1α mediated atherosclerotic plaque formation.

Conditions

Interventions

Eligibility

Locations (8)

Outcomes