The final 12-month results of the Stellarex (Spectranetics) drug-coated balloon ILLUMENATE Global Study have found high primary patency and freedom from clinically driven target lesion revascularisation results.
The ILLUMENATE Global Study is a prospective, multicentre, single-arm study designed to assess the clinical performance of the Stellarex drug-coated balloon in the superficial femoral and popliteal arteries.
The results were presented by Thomas Zeller, professor of Angiology, Albert-Ludwigs University of Freiburg, and head of the Department of Angiology, Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany, at the Leipzig Interventional Course (LINC) in Leipzig, Germany.
The ILLUMENATE Global Trial enrolled 371 patients. The treated lesions were highly complex, including a high proportion of chronic total occlusions (31%) and severe calcification (41%), as reported by an independent angiographic core-laboratory. The key results, per Kaplan-Meier survival estimates at day 365, include:
– Primary patency was 81.4%
– Freedom from clinically-driven target lesion revascularization (CD-TLR) was 94.8%
“In a real-world setting, ILLUMENATE Global validates the earlier ILLUMENATE US Pivotal results, achieving best-in-class 12-month primary patency rates in a patient cohort with the highest rate of severe calcium yet studied. These results are significant because severe calcium has been one of the greatest challenges in our drug-coated balloon practice,” says Zeller.