NCT00598676

3 Limus Agent Eluting Stents With Different Polymer Coating

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,600 (actual)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DEVICE	biodegradable polymer Rapamycin-eluting stent	due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
DEVICE	permanent polymer rapamycin-eluting stent (Cypher)	due to randomization, rapamycin-eluting stent with permanent polymer will be implanted
DEVICE	permanent polymer everolimus-eluting stent (Xience, Promus)	due to randomization, everolimus-eluting stent with permanent polymer will be implanted

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2008-01-22
• Last updated: 2010-03-15

Locations

2 sites across 1 country: Germany