Home   Distributors   Careers   Contact

 

DESolve® Nx Trial

OVERVIEW

The DESolve Nx Trial is multi-center, prospective single arm study enrolling 126 patients at up to 15 centers in Germany, Belgium, Poland, Brazil and New Zealand designed to evaluate the safety and efficacy of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System (CSS). The study device is comprised of a fully bioresorbable polylactide-based scaffold coated with a polylactide-based resorbable polymer-drug matrix. The principal imaging endpoint is in-stent late lumen loss assessed by QCA at 6 months for all patients. In a sub-set of more than 35 patients enrolled at select centers, in-stent late lumen loss will be evaluated by QCA at 6 and 36 months; stent and vessel assessment using IVUS, OCT will be conducted at baseline, 6 and 24 months; and multi-slice computed tomography (MSCT) at 12 months thus providing long-term assessment of the scaffold and surrounding vessel. The principal safety endpoint is the composite of major adverse cardiac events (MACE) comprised of cardiac death, target vessel myocardial infarction (MI) and clinically-indicated target vessel revascularization (TLR).

  • 126 patients enrolled at up to 15 sites in Belgium, Germany, Poland, Denmark, Brazil and New Zealand
  • Geographical Coordinating Investigators:
    • Alexandre Abizaid, MD, PhD – Brazil
    • John Ormiston, MBChB - New Zealand
    • Stefan Verheye, MD, PhD and Joachim Schofer, MD, PhD - Europe
  • Up to two de novo native coronary arteries in separate epicardial vessels can be treated
    • Target lesion treated with the DESolve Scaffold
    • Non-target lesion treated with a commercially available stent
  • Clinical follow-up at 30 days, 6, 12 months, and 2 – 5 years
  • Angiographic follow-up at 6 months for all patients
  • Sub-set of 35 patients will have angiographic, IVUS, and OCT follow-up at 6 and 24 months
  • MSCT follow-up at 12 months
  • Available scaffold size: 3.0 x 14mm, 3.0 x 18mm, 3.25 x 14mm, 3.25 x 18mm, 3.5 x 14 mm and 3.5 x 18 mm
  • Novolimus drug dose: 5mcg per mm of scaffold length
  • Bioabsorption rate:
    • Coating : 6- 9 months
    • Scaffold: 1 – 2 years

Learn more