HEALING IIb Trial Design

Genous Bio-Engineered Rstent, Design Matters
Title: HEALING IIb, Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth
Study Principal Investigator: Prof. P.W. Serruys, MD
Objective: Evaluate the safety and effectiveness of the Genous Bio-engineered R stentTM in conjunction with optimal statin therapy (80mg of atorvastatin), in the treatment of elective patients with up to two de novo native coronary artery lesions
Indication: De novo lesions in native coronary arteries w/ reference vessels from 2.5- 3.75 mm
Study Design:
  • Multi-center, prospective, non-randomized trial, 90 patients
  • One month clinical follow up
  • Six months angiographic follow up
  • Eighteen months angiographic follow up
  • Yearly up to five years clinical follow up

Primary Endpoint:

Secondary Endpoints:
  • in-stent late loss at 6 months by Quantitative Coronary Angiography (QCA)
  • Angiographic success
  • Procedure success
  • Angiographic and/or clinical stent thrombosis
  • In-stent late loss at 18 months
  • Binary restenosis rate at 6 and 18 months
  • In-segment late loss at 6 and 18 months
  • Volumetric assessment (derived from QCA parameters) at 6 and 18 months
  • Circulating endothelial progenitor cell (EPC) count at screening, index procedure and at 30 days
  • Target Vessel Failure (TVF) at 30 days, 6, 12, 18 months and at 2, 3, 4 and 5 years

 
Status: Enrollment initiated in August 2006
Participating Centers:

Austria

  • Medizinische Universitätsklinik, Graz

Belgium

  • Virga Jesse Ziekenhuis, Hasselt
  • Onze Lieve Vrouwe Ziekenhuis, Aalst
  • Academisch Ziekenhuis Middelheim, Antwerpen
  • UZA, Antwerp

France

  • Hopital Henri Mondor, Créteil

Germany

  • Kardiologische Klinik Dr. Müller-Herzkatherlabor, München
  • Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeyenhausen
  • Krankenhaus Neuperlach, München

Italy

  • Università Campus BIOMEDICO, Roma

The Netherlands

  • Erasmus Universiteit MC, Rotterdam
  • Academisch Medisch Centrum, Amsterdam
  • Amphia Ziekenhuis, Breda
  • Sint Antonius Ziekenhuis, Nieuwegein

UK

  • Kings College, London
  • John Radcliffe Hopital, Oxford