Two-year results of a low-dose drug-coated balloon for revascularization of the femoropopliteal artery: outcomes from the ILLUMENATE first-in-human study.

Objectives: To assess the safety and effectiveness of the Stellarex™ drug-coated angioplasty balloon (DCB) to inhibit restenosis in the superficial femoral and/or popliteal artery.

Background: Treatment of peripheral arterial disease is challenged by restenosis, requiring revascularization procedures to maintain patency. DCBs are designed to deliver an anti-proliferative drug to the vessel wall to diminish smooth muscle cell proliferation and maintain patency.