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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.

Author information

1
Ziekenhuis Oost-Limburg, Genk, Belgium.
2
Department of Interventional Radiology, Auckland City Hospital, Auckland, New Zealand.
3
CHU de Nantes, Nantes, France.
4
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.
5
Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.
6
Department of Vascular Surgery, Heilig Hart Hospital, Tienen, Belgium.
7
Medical Department II, Experimental Angiology, University Hospital Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.
8
Department of Cardiology, University Hospital Hamburg Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.
9
Max-Planck Institute of Heart and Lung Research, Ludwigstraße 43, 61231, Bad Nauheim, Germany.
10
Cardiovascular Center Oberallgaeu-Kempten, Academic Teaching Hospital, University of Ulm, Im Stillen 2, Immenstadt, 87509, Germany.
11
Department of Vascular Surgery, Universitair Ziekenhuis Gent, Ghent, Belgium.
12
GVM Care & Research Interventional Cardiology Unit, Maria Cecilia Hospital, Cotignola, Italy.
13
SRH Klinikum Karlsbad Langensteinbach, Karlsbad, Germany.
14
VasCore, Massachusetts General Hospital, Boston, MA.
15
Angiology Division, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.

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.

KEYWORDS:

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

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