Curtin University Homepage
  • Library
  • Help
    • Admin

    espace - Curtin’s institutional repository

    JavaScript is disabled for your browser. Some features of this site may not work without it.
    View Item 
    • espace Home
    • espace
    • Curtin Research Publications
    • View Item
    • espace Home
    • espace
    • Curtin Research Publications
    • View Item

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

    Access Status
    Fulltext not available
    Authors
    Schroë, H.
    Holden, A.
    Goueffic, Y.
    Jansen, Shirley
    Peeters, P.
    Keirse, K.
    Ito, W.
    Vermassen, F.
    Micari, A.
    Blessing, E.
    Jaff, M.
    Zeller, T.
    Date
    2018
    Type
    Journal Article
    
    Metadata
    Show full item record
    Citation
    Schroë, H. and Holden, A. and Goueffic, Y. and Jansen, S. and Peeters, P. and Keirse, K. and Ito, W. et al. 2018. 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. 91 (3): pp. 497-504.
    Source Title
    Catheterization and Cardiovascular Interventions
    DOI
    10.1002/ccd.27348
    ISSN
    1522-1946
    School
    Curtin Medical School
    URI
    http://hdl.handle.net/20.500.11937/73398
    Collection
    • Curtin Research Publications
    Abstract

    © 2017 The Authors. Catheterization and Cardiovascular Interventions Published by Wiley Periodicals, Inc. 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.

    Related items

    Showing items related by title, author, creator and subject.

    • Utility of the ACC/AHA lesion classification as a predictor of procedural, 30-day and 12-month outcomes in the contemporary percutaneous coronary intervention era.
      Theuerle, J.; Yudi, M.; Farouque, O.; Andrianopoulos, N.; Scott, P.; Ajani, A.; Brennan, Angela; Duffy, S.; Reid, Christopher; Clark, D.; Melbourne Interventional Group. (2017)
      BACKGROUND: Correlations between the ACC/AHA coronary lesion classification and clinical outcomes in the contemporary percutaneous coronary intervention (PCI) era are not well established. METHODS: We analyzed clinical ...
    • Recent trends in Australian percutaneous coronary intervention practice: Insights from the melbourne interventional group registry
      Yan, B.; Ajani, A.; Clark, D.; Duffy, S.; Andrianopoulos, N.; Brennan, A.; Loane, P.; Reid, Christopher (2011)
      Objective: To evaluate percutaneous coronary intervention (PCI) practice trends and 12-month outcomes in Australia in the era of drug-eluting stents (DES). Design, setting and patients: Prospective study of consecutive ...
    • Quantitative comparison of cortical and deep grey matter in pathological subtypes of unilateral cerebral palsy
      Scheck, S.; Pannek, K.; Fiori, S.; Boyd, Roslyn; Rose, S. (2014)
      © 2014 Mac Keith Press. Aim: The aim of this study was to quantify grey matter changes in children with unilateral cerebral palsy (UCP), differentiating between cortical or deep grey matter (CDGM) lesions, periventricular ...
    Advanced search

    Browse

    Communities & CollectionsIssue DateAuthorTitleSubjectDocument TypeThis CollectionIssue DateAuthorTitleSubjectDocument Type

    My Account

    Admin

    Statistics

    Most Popular ItemsStatistics by CountryMost Popular Authors

    Follow Curtin

    • 
    • 
    • 
    • 
    • 

    CRICOS Provider Code: 00301JABN: 99 143 842 569TEQSA: PRV12158

    Copyright | Disclaimer | Privacy statement | Accessibility

    Curtin would like to pay respect to the Aboriginal and Torres Strait Islander members of our community by acknowledging the traditional owners of the land on which the Perth campus is located, the Whadjuk people of the Nyungar Nation; and on our Kalgoorlie campus, the Wongutha people of the North-Eastern Goldfields.