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Catheter Cardiovasc Interv. 2018 Feb 15;91(3):497-504. doi: 10.1002/ccd.27348. Epub 2017 Oct 31.

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

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Ziekenhuis Oost-Limburg, Genk, Belgium.
Department of Interventional Radiology, Auckland City Hospital, Auckland, New Zealand.
CHU de Nantes, Nantes, France.
Vascular and Endovascular Surgery, Sir Charles Gairdner Hospital, Health and Medical Sciences, University of Western Australia, School of Population Health, Curtin University, Perth, Western Australia.
Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.
Department of Vascular Surgery, Heilig Hart Hospital, Tienen, Belgium.
Medical Department II, Experimental Angiology, University Hospital Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.
Department of Cardiology, University Hospital Hamburg Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
Max-Planck Institute of Heart and Lung Research, Ludwigstraße 43, 61231, Bad Nauheim, Germany.
Cardiovascular Center Oberallgaeu-Kempten, Academic Teaching Hospital, University of Ulm, Im Stillen 2, Immenstadt, 87509, Germany.
Department of Vascular Surgery, Universitair Ziekenhuis Gent, Ghent, Belgium.
GVM Care & Research Interventional Cardiology Unit, Maria Cecilia Hospital, Cotignola, Italy.
SRH Klinikum Karlsbad Langensteinbach, Karlsbad, Germany.
VasCore, Massachusetts General Hospital, Boston, MA.
Angiology Division, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.



The purpose of this study was to assess the safety and performance of Stellarex Drug-coated balloon (DCB).


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.


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.


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.


This study validated previous positive findings and confirms the strong safety profile and effectiveness outcomes.


drug-coated balloon; peripheral arterial disease; superficial femoral artery

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