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  • Title: Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study.
    Author: Schroë H, Holden AH, Goueffic Y, Jansen SJ, Peeters P, Keirse K, Ito W, Vermassen F, Micari A, Blessing E, Jaff MR, Zeller T.
    Journal: Catheter Cardiovasc Interv; 2018 Feb 15; 91(3):497-504. PubMed ID: 29086462.
    Abstract:
    OBJECTIVES: The purpose of this study was to assess the safety and performance of Stellarex Drug-coated balloon (DCB). BACKGROUND: DCB 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. METHODS: The 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. RESULTS: In 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. CONCLUSIONS: This study validated previous positive findings and confirms the strong safety profile and effectiveness outcomes.
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