Clinical Trials Directory

Trials / Completed

CompletedNCT01331707

DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population

DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity (DUTCH PEERS): Randomized Multicenter Trial in All Comers Population Treated Within Eastern NeThErlands-2 (TWENTE-2)

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
1,811 (actual)
Sponsor
Foundation of Cardiovascular Research and Education Enschede · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance. Such demands are an optimized performance in very challenging coronary lesions; third generation DES were developed in an effort to further improve DES performance in such challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus Element stents) are currently available; there are no data that indicate an advantage of one of these DES over the other.

Conditions

Interventions

TypeNameDescription
DEVICEResolute Integrity (Zotarolimus-eluting stent)Third generation drug-eluting stent
DEVICEPromus Element (Everolimus-eluting stent)Third generation drug-eluting stent

Timeline

Start date
2010-11-01
Primary completion
2012-12-01
Completion
2013-12-01
First posted
2011-04-08
Last updated
2015-07-28

Locations

4 sites across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT01331707. Inclusion in this directory is not an endorsement.