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

NCT01674803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3514

Last updated 2022-07-20

No results posted yet for this study

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

DEVICE

Orsiro

biodegradable polymer sirolimus eluting stent

DEVICE

Synergy

biodegradable polymer everolimus eluting stent

DEVICE

Resolute Integrity

durable polymer zotarolimus-eluting stent

Sponsors & Collaborators

  • Foundation of Cardiovascular Research and Education Enschede

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-21
Primary Completion
2016-08-24
Completion
2020-08-25

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01674803 on ClinicalTrials.gov