The intracoronary stents remain as implants in the coronary arteries during the whole life; thus, the stents have to be investigated with in-vitro-(bench-) and in-vivo-tests before first implantation in the human body, according to the very strict criteria for the approval of a stent in Europa (CE-certification) and in the USA (Food and Drug Administration-rules). In-vitro-tests of stents are performed by special equipments; in-vivo-tests involve intracoronary implantation in pig coronary arteries. The rules for the in-vivo-tests of bare metal stents are in accordance with the "FDA guidelines for animal studies" and of drug-eluting stents with the "FDA Guidelines - Recommended Standards for Preclinical Studies and Evaluation of Drug-eluting stents". Virmani et al. published the conclusions about the necessity of the preclinical (animal) studies before approval of stents for human use. The animal model of stenting predicts human responses, as the stages of healing are remarkably similar. Our experimental group performs preclinical studies of stenting in coronary arteries of pigs since Mai 2000. One of the specialties of our group is an intravascular ultrasound (IVUS) investigation by the follow-up control angiography, which provides an immediately macroscopic result of the coronary stents. Further advantage of the IVUS is the possibility for exact evaluation of the amount and localization of the neointimal hyperplasia, in contrast with the histology. Beside the measurement of neointimal hyperplasia, the animal experiments provide further valuable information about the effectivity of antithrombotic therapy, mechanism of plaque growth, time-dependent release of cytokines, and platelet-activation in relation of thrombotic stent-occlusion.
|Translated title of the contribution||Intracoronary stents: From factory to human coronary arteries - Preclinical evaluation of coronary stents|
|Number of pages||7|
|Journal||Journal fur Kardiologie|
|Publication status||Published - Dec 23 2004|
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine