NCT01068106

Test Efficacy of Biodegradable and Permanent Limus-Eluting Stents

Prospective, Randomized Trial of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coatings

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,010 (estimated)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this prospective, randomized study is to compare the efficacy and safety of biodegradable polymer based limus-eluting stents (BPDES) with permanent polymer based everolimus eluting stents (PPDES).

Detailed description

Restenosis affects 20-40% of de novo coronary lesions treated with bare-metal stents. Although it is often considered a benign process, recent data indicate that in-stent restenosis has a negative impact on long-term survival of patients treated with coronary stents. Drug eluting stents have emerged as the most effective strategy for the prevention of restenosis. A large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare-metal stents. Available evidence shows that all 3 limus drugs - rapamycin, everolimus and biolimus - are very effective in suppressing neointima formation after coronary stenting. Drugs are fully released within a few weeks from the majority of current DES. However, most of the DES use permanent polymers, which continue to remain in the vessel wall even after accomplishing their drug-release mission. Their permanent presence may be associated with persistent inflammatory reaction and delayed neointimal proliferation and vessel thrombosis. Clinical trial evidence with biodegradable polymer DES is still limited, but there are great expectations that this DES technology might be the dominant one in the years to come.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DEVICE	Nobori® (Biodegradable polymer limus-eluting stents)	due randomization biodegradable polymer limus-eluting stents will be implanted
DEVICE	Xience-V® (Permanent polymer limus-eluting stent)	due randomization permanent polymer limus-eluting stent will be implanted

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-09-01
• Completion: 2013-09-01
• First posted: 2010-02-12
• Last updated: 2012-05-08

Locations

2 sites across 1 country: Germany