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BIOFREEDOM Stent Versus ORSIRO Stent: SORT OUT IX (SORT OUT IX)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02623140
First Posted: December 7, 2015
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Aarhus University Hospital Skejby
Aalborg Universitetshospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Lisette Okkels Jensen, Odense University Hospital
  Purpose
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

Condition Intervention Phase
Ischaemic Heart Disease Device: Biofreedom Device: Orsiro Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Comparison of a Polymer-Free Biolimus-eluting BIOFREEDOM Stent With a Biodegradable-Polymer Sirolimus-eluting ORSIRO Stent in Patients Treated With Percutaneous Coronary Intervention

Further study details as provided by Lisette Okkels Jensen, Odense University Hospital:

Primary Outcome Measures:
  • Target Lesion Failure [ Time Frame: 12 months ]
    Primary endpoint assessed after 12 months


Secondary Outcome Measures:
  • Target lesion failure [ Time Frame: 2 year, 3 year, 4 year, 5 year ]
    Target lesion failure will be assessed yearly up to 5 years after index procedure

  • Stent thrombosis [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Stent thrombosis will be assessed yearly up to 5 years after index procedure

  • Myocardial infarction [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Myocardial infarction will be assessed yearly up to 5 years after index procedure

  • Cardiac death [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Cardiac death will be assessed yearly up to 5 years after index procedure

  • All cause mortality [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    All cause mortality will be assessed yearly up to 5 years after index procedure

  • Target lesion revascularization [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Target lesion revascularization will be assessed yearly up to 5 years after index procedure

  • Target vessel revascularization [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Target vessel revascularization will be assessed yearly up to 5 years after


Estimated Enrollment: 3150
Study Start Date: December 2015
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biofreedom
Biofreedom stent treatment at index procedure
Device: Biofreedom
PCI with Biofreedom stent
Active Comparator: Orsiro
Orsiro stent treatment at index procedure
Device: Orsiro
PCI with Orsiro stent

Detailed Description:

SORT OUT IX is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in treating atherosclerotic coronary artery lesions.

Patients will be enrolled by the investigators and randomly allocated to treatment groups after diagnostic coronary angiography and before percutaneous coronary intervention. Block randomization by centre (permuted blocks of random sizes (2/4/6)) will be used to assign patients in a 1:1 ratio to receive the polymer-free Biolimus-eluting BIOFREEDOM stent (Biosensors) or the biodegradable-polymer Sirolimus-eluting ORSIRO stent (Biotronik). A web based Trial Partner randomization system will be used.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent.

Exclusion Criteria:

  • Life expectancy of less than one year; an allergy to aspirin, clopidogrel, ticagrelor, prasugral, biolimus or sirolimus; participation in another randomized trial; or inability to provide written informed consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623140


Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Aarhus University Hospital Skejby
Aalborg Universitetshospital
Rigshospitalet, Denmark
Investigators
Study Chair: Lisette Okkels Jensen, MD DMSci PhD Odense University Hospital
Study Chair: Evald H Christiansen, MD PhD Aarhus University Hospital
  More Information

Responsible Party: Lisette Okkels Jensen, MD DMSci PhD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02623140     History of Changes
Other Study ID Numbers: SORT OUT IX
First Submitted: November 30, 2015
First Posted: December 7, 2015
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Lisette Okkels Jensen, Odense University Hospital:
Coronary drug eluting stents
Outcomes

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases