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Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents

NCT02508714 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2470

Last updated 2017-02-03

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 bioresorbable 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 bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.

Conditions

  • Coronary Artery Disease
  • Angina Pectoris
  • Unstable Angina Pectoris
  • Acute Coronary Syndrome
  • Coronary Stenosis
  • Coronary Restenosis

Interventions

DEVICE

Orsiro

stents will be implanted in case of significant coronary artery disease

DEVICE

Resolute Onyx

stents will be implanted in case of significant coronary artery disease based on coronary angiography

Sponsors & Collaborators

  • Thorax Centrum Twente

    lead OTHER

Principal Investigators

  • Clemens von Birgelen, MD, PhD · Thorax Centrum Twente

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-07
Primary Completion
2018-03-31
Completion
2019-03-31

Countries

  • Belgium
  • Israel
  • 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 NCT02508714 on ClinicalTrials.gov