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

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions
Herman SchroëThomas Zeller

Abstract

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 indep...Continue Reading

Associated Clinical Trials

References

Dec 24, 2004·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Knut KrögerMathias Goyen
May 5, 2006·The New England Journal of Medicine·Martin SchillingerErich Minar
Oct 12, 2011·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Peter W RadkeEric Wittchow
Feb 9, 2012·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·John R LairdUNKNOWN RESILIENT Investigators
Feb 8, 2014·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Ehrin J ArmstrongJohn R Laird
May 9, 2014·Cardiovascular and Interventional Radiology·F FanelliF M Salvatori
Feb 25, 2015·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Henrik SchroederStephan Duda
Mar 17, 2015·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Dierk ScheinertGunnar Tepe
May 15, 2015·Circulation. Cardiovascular Interventions·Lawrence GarciaUNKNOWN SUPERB Trial Investigators
Jun 25, 2015·The New England Journal of Medicine·Kenneth RosenfieldUNKNOWN LEVANT 2 Investigators
Oct 20, 2015·Journal of the American College of Cardiology·John R LairdUNKNOWN IN.PACT SFA Trial Investigators
Apr 9, 2016·JACC. Cardiovascular Interventions·Andrej SchmidtDierk Scheinert

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Citations

Dec 28, 2018·Circulation·Diane Treat-JacobsonUNKNOWN American Heart Association Council on Peripheral Vascular Disease; Council on Quality of Care and Outcomes Research; and Cou
Mar 7, 2019·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Mahesh Anantha-NarayananCarlos Mena-Hurtado
Jun 18, 2019·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Ehrin J ArmstrongPeter A Schneider
Jun 18, 2019·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Zhong ChenMichael R Jaff
Oct 3, 2019·Expert Review of Cardiovascular Therapy·Stefanos Giannopoulos, Ehrin J Armstrong
Jan 29, 2020·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Gunnar TepeMarianne Brodmann
Jun 26, 2020·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Giovanni TorselloUNKNOWN IN.PACT Global Investigators
Sep 1, 2020·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Yoshimitsu SogaHiroyoshi Yokoi
Jul 28, 2020·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Bhaskar PurushottamPrakash Krishnan
Jun 27, 2019·The Journal of Cardiovascular Surgery·Konstantinos StavroulakisBella Huasen
Jul 16, 2019·Journal of Endovascular Therapy : an Official Journal of the International Society of Endovascular Specialists·Martin WernerReinhold Tischler
Jul 4, 2020·Expert Opinion on Drug Delivery·Roberto NerlaAntonio Micari
Apr 9, 2021·Annals of Vascular Surgery·Bibombe Patrice MwipatayiUNKNOWN BIOLUX P-III Global Registry Investigators
Oct 8, 2021·Circulation Journal : Official Journal of the Japanese Circulation Society·Yoshimitsu SogaUNKNOWN IN.PACT Japan Post-Market Surveillance Study
Dec 24, 2021·Circulation. Cardiovascular Interventions·Jennifer A RymerKim G Smolderen

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Methods Mentioned

BETA
dissection
amputation

Clinical Trials Mentioned

NCT01927068

Software Mentioned

LEVANT

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