Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study.

Abstract

ObjectivesThe purpose of this study was to assess the safety and performance of Stellarex Drug‐coated balloon (DCB).BackgroundDCB coatings differ in excipients, paclitaxel dose, and coating morphologies. Due to these differences, a class effect with DCBs has not been demonstrated. Consequently, each DCB needs to be evaluated independently based on its own clinical study results.MethodsThe ILLUMENATE Global Study is a prospective, multicenter, single‐arm study. Patients with intermittent claudication or ischemic rest pain due to superficial femoral artery (SFA) and/or popliteal peripheral artery disease (PAD) were treated with the Stellarex DCB. The primary efficacy endpoint was primary patency, defined as freedom from restenosis with peak systolic velocity ratio ≤2.5 or clinically‐driven target lesion revascularization (CD‐TLR) at 12 months. The primary safety endpoint was freedom from device and procedure‐related death through 30 days postprocedure and freedom from target limb major amputation and CD‐TLR through 12 months.ResultsIn total, 417 lesions were treated in 371 patients. The mean lesion length was 7.5 ± 5.3 cm, 40.8% of lesions were severely calcified per core laboratory fluoroscopy criteria and 31.3% were total occlusions. Primary patency by independent duplex core lab evaluation was 81.4% and the freedom from CD‐TLR was 94.8% day 365 per Kaplan‐Meier estimate. The majority of patients experienced improvements in their Rutherford classification (90.3%) and walking impairment questionnaire score (83.6%) at 12 months compared to baseline.ConclusionsThis study validated previous positive findings and confirms the strong safety profile and effectiveness outcomes.