biodegradable polymer Rapamycin-eluting stent
Devicedue to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
Other names: ISAR stent
NCT Number: NCT00598676
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Deutsches Herzzentrum Muenchen, Munich, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
Other names: ISAR stent
due to randomization, rapamycin-eluting stent with permanent polymer will be implanted
Other names: Cypher
due to randomization, everolimus-eluting stent with permanent polymer will be implanted
Other names: Xience, Promus
Time frame: 12 months
Time frame: 6-8 months
Time frame: 6-8 months
Time frame: 12 months
Time frame: 12 months
Deutsches Herzzentrum Muenchen
Other
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
Acronym: ISAR-TEST-4
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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