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DIOR® – CLINICAL PROGRAM

Evidence for the safety and efficacy of the DIOR® DEB in CAD

DIOR® in in-stent restenosis (ISR)

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Valentines Trial

  • International prospective multicenter registry
  • 250 patients with coronary DES and BMS in-stent restenosis (ISR)
  • 8 months follow-up
  • Clinical safety and low MACE rate at follow-up in a real world ISR population.

Spanish Registry

  • Prospective multicenter registry
  • 126 patients with coronary DES and BMS in-stent restenosis (ISR)
  • 12 months follow-up
  • Clinical safety and low MACE rate at follow-up in a real world ISR population.
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Stella PR et al. “The Valentines Trial: results of the fi rst one week worldwide multicentre enrolment trial, evaluating the real world usage of the second generation DIOR paclitaxel drug-eluting balloon for in-stent restenosis treatment.” EuroIntervention 2011 7(6): 705-710.

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Loh JP et al. “Paclitaxel-coated balloon for the treatment of drug-eluting stent restenosis: subanalysis results from the Valentines I trial.” Cardiovasc Revasc Med 2014 15(1): 23-28.

DIOR® in bifrucation lesions

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001 Trial

  • Prospective multicenter registry
  • 49 patients with coronary de novo Medina 001 bifurcation lesions
  • 12 months follow-up
  • DIOR® as a safe and technically easy option for treatment of
    sidebranch ostial lesions (001 bifurcations).

DEBIFU Registry

  • Prospective multicenter registry
  • 100 patients with coronary bifurcation lesions
  • 12 months follow-up
  • DIOR® is a safe alternative in complex bifurcation lesion with
    low MACE rate at follow-up.
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Vaquerizo B et al. “Second-Generation Drug-Eluting Balloon for Ostial Side Branch Lesions (001-Bifurcations): Mid-Term Clinical and Angiographic Results.” Journal of interventional cardiology 2016 29(3): 285-292.

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von Korn et al. “Interventional therapy of bifurcation lesions: a new approach using drug-eluting balloons for the main branch and/or for the side branch the DEBIFU Registry” Presentation at EuroPCR Paris 2016

DIOR® in de-novo lesions

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Valentines Trial II

  • International prospective multicenter registry
  • 103 patients with coronary de novo lesions
  • 8 months follow-up
  • Clinical safety and low MACE rate at follow-up in a real de novo lesion population
    (2.40 mm mean reference vessel diameter) with low bail-out stenting rate.

DEAR Registry

  • Prospective multicenter registry
  • 91 diabetic patients with de novo lesions
  • 12 months follow-up
  • Significantly lower MACE rate for DIOR® vs. BMS comparison group.
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Waksman R et al. “Drug-coated balloons for de novo coronary lesions: results from the Valentines II trial.” EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 2013 9(5): 613-619.

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Mieres J et al. “One-year outcome of patients with diabetes mellitus after percutaneous coronary intervention with three different revascularization strategies: results from the Diabetic Argentina Registry (DEAR).” Cardiovasc Revasc Med 2012 13(5): 265-271.

DIOR® in small vessels

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Spanish Registry

  • Prospective multicenter registry
  • 104 patients with native coronary small vessel lesions
  • 12 months follow-up
  • Clinical safety and very low MACE rate in real small vessels (< 2.0 mm)
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Vaquerizo B et al. “Treatment of small vessel disease with the paclitaxel drug-eluting balloon: 6-Month angiographic and 1-Year clinical outcomes of the Spanish Multicenter Registry.” J INTERV CARDIOL 2015 28(5): 430-438.