Clinical Trials Directory

Trials / Completed

CompletedNCT01674803

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion (BIO-RESORT)

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion: Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
3,514 (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. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with biodegradable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such biodegradable polymer DES are increasingly used in clinical practice, there is no data available from head-to-head comparisons between biodegradable and contemporary third generation durable polymer DES.

Conditions

Interventions

TypeNameDescription
DEVICEOrsirobiodegradable polymer sirolimus eluting stent
DEVICESynergybiodegradable polymer everolimus eluting stent
DEVICEResolute Integritydurable polymer zotarolimus-eluting stent

Timeline

Start date
2012-12-21
Primary completion
2016-08-24
Completion
2020-08-25
First posted
2012-08-29
Last updated
2022-07-20

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT01674803. Inclusion in this directory is not an endorsement.