| 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
|
