NCT00598715

Efficacy Study of Two Different Strategies for Restenosis in Sirolimus-Eluting Stents

Randomized Trial of Paclitaxel- vs Sirolimus-eluting Stents for Treatment of Coronary Restenosis in Sirolimus-eluting Stents

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For lesions which develop restenosis after a drug-eluting stent, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug.

Detailed description

Treatment of in-stent restenosis after implantation of a DES has poorly been studied. Although there are no data, it may be assumed that certain lesions might be resistant to a given drug and in need of a different DES. Thus, for lesions which develop restenosis after a DES, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug. This prospective, randomized trial will compare the anti-restenotic efficacy of PES or SES in patients with restenosis after initial implantation of a SES

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Sirolimus eluting stent	Sirolimus-eluting stent will be implanted
DEVICE	Paclitaxel-eluting stent	Paclitaxel-eluting stent will be implanted

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-01-22
• Last updated: 2010-12-17

Locations

2 sites across 1 country: Germany