Coronary Heart Disease Clinical Trial
Official title:
Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting STents (ISAR-TEST 4): Prospective, Randomized Trial of 3-limus Agent-eluting Stents With Different Polymer Coatings
The aim of this study is to determine whether biodegradable polymer based rapamycin-eluting stent performs equal to permanent polymer based everolimus- and rapamycin-eluting stents regarding reduction of adverse cardiac events at one year.
Drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for
target vessel revascularisation compared with bare metal stents. Although this applies to
the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been
completely eliminated and remain to occur in certain high risk subgroups. Thus there is
ongoing research for new, potentially more effective and safe drug-eluting stent systems.
One direction of extensive research is the search of new polymers such as biodegradable
polymers which allow a controlled drug-release and disappear with time, reducing the
probability of polymer-induced chronic inflammation on the vessel wall.
Another direction is finding new drugs to suppress neointimal hyperplasia. Promising
preclinical and clinical results suggest that the Everolimus eluting stent platform might
provide potential improvements over prior generations of drug-eluting stents.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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