HEALING II Trial Design

Genous Bio-Engineered Rstent, Design Matters
Title: HEALING II, Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth
Objective: Demonstrate the safety, efficacy, and stent related healing towards a stent designed for EPC capture.
Indication: De novo and non-stented restenotic lesions in native coronary arteries w/ reference vessels from 2.5- 3.5 mm
Study Design:
  • Multi-center, prospective, non-randomized trial
  • thirty days clinical follow up
  • Six months clinical, QCA, and IVUS follow up
  • Nine months clinical follow up
Design Endpoints:

Clinical:

  • MACE at 30 days
  • 63 patients; 10 centers
  • Study Principal Investigator: Prof. P.W. Serruys, MD

Angiographic: QCA and IVUS at six months
Status: Enrollment initiated in May 2004
Participating Centers:

Belgium

  • Virga Jesse Ziekenhuis, Hasselt
  • Middelheim Ziekenhuis, Antwerp
  • Onze Lieve Vrouwe Gasthuis, Aalst

Germany

  • Kerckhoff Herz Zentrum, Bad Nauheim
  • Krankenhaus-Neuperlach, München
  • Kardiologische Klinik Dr. Müller, München

The Netherlands

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