NCT00825279

A Trial Comparing a Paclitaxel Eluting Stent With Biodegradable Polymer Versus a Bare Metal Stent

Comparison Among a Paclitaxel Eluting Stent With Biodegradable Polymer Versus an Uncoated Bare Metal Stent. A Prospective, Multicentric and Randomized Study.(EUCATAX Trial)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Centro de estudios en Cardiologia Intervencionista · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The success of stent implantation has led to the increasingly widespread use of them in the treatment of coronary artery disease (Sigwart, Serruys, Fischman)and although stent restenosis is still a limit for this therapeutic mode (Serruys, Rodriguez) the new generation of stents with improved coating materials and the development of polymers that release different kinds of drugs that prevent the activation and/or proliferation of smooth muscle cells (ultimate cause of restenosis) (Grube, Rodriguez). shows major improvements on this matter. The new generation of stents with biodegradable polymers and short time of drug release gives new advantages to this therapeutic, multiple studies and registries challenge this new devices (Taxus I and II, RAVEL, SIRIUS, ERACI II and III). For this reason the present study aims to compare a stainless steel stent with a drug eluting stent with coated of biodegradable polymer matrix hemoparin and paclitaxel.

Detailed description

Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina were randomized to treat with a stainless steel stent ("euca STS Flex") or a drug-eluting stent (" euca STS Flex DE") with a coating of a biodegradable polymer matrix of hemoparin and paclitaxel.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Bare Metal Stent	Stainless steel stent
DEVICE	Drug Eluting Stent	stent coated with the biodegradable polymer matrix hemoparin and paclitaxel

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-01-21
• Last updated: 2010-05-28

Locations

2 sites across 1 country: Argentina