The trial is a randomized, open-label, prospective, multicenter study that will compare the safety and efficacy of three different Coroxane dosing schedules to primary percutaneous balloon angioplasty with provisional stenting, the standard treatment for stenosis. Approximately 150 patients will be monitored for restenosis of the target vessel at nine months as evaluated by angiography and duplex ultrasound.
John Rundback, principal investigator of the study, said: “The present study is an important step forward in providing a treatment alternative to patients with moderate to long segment superficial femoral artery disease using Coroxane, which is a drug with proven benefit for the suppression of restenosis. The novel mode of delivery allows platform independent treatment and can be used regardless of the initial revascularization method.”