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BIOFREEDOM Stent Versus ORSIRO Stent: SORT OUT IX

NCT02623140 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3150

Last updated 2020-09-18

No results posted yet for this study

Summary

The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is to compare the safety and efficacy of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in a population-based setting, using registry detection of clinically driven events

Conditions

  • Ischaemic Heart Disease

Interventions

DEVICE

Biofreedom

PCI with Biofreedom stent

DEVICE

Orsiro

PCI with Orsiro stent

Sponsors & Collaborators

  • Aarhus University Hospital Skejby

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Lisette Okkels Jensen, MD DMSci PhD · Odense University Hospital

  • Evald H Christiansen, MD PhD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-10-31
Completion
2023-10-31

Countries

  • Denmark

Study Locations

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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 NCT02623140 on ClinicalTrials.gov