Ischaemic Heart DiseaseSORT OUT IXNCT02623140
BIOFREEDOM Stent Versus ORSIRO Stent: SORT OUT IX
A study testing Biofreedom and Orsiro in people with Ischaemic Heart Disease, run by Odense University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischaemic Heart Disease
- What is being tested?
- Biofreedom and Orsiro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,150 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2015to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Ischaemic Heart Disease
- Being tested
- Biofreedom, Orsiro
- Keywords
- Coronary drug eluting stents, Outcomes
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofreedomDevice
PCI with Biofreedom stent
OrsiroDevice
PCI with Orsiro stent
| Study group | Role | What they receive |
|---|---|---|
| Biofreedom | Experimental | Biofreedom stent treatment at index procedure Receives: Device: Biofreedom |
| Orsiro | Active comparator | Orsiro stent treatment at index procedure Receives: Device: Orsiro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure
Primary endpoint assessed after 12 months
Measured: 12 months
Secondary outcomes (7)
Target lesion failure
Target lesion failure will be assessed yearly up to 5 years after index procedure
Measured: 2 year, 3 year, 4 year, 5 year
Stent thrombosis
Stent thrombosis will be assessed yearly up to 5 years after index procedure
Measured: 1 year, 2 years, 3 years, 4 years, 5 years
Myocardial infarction
Myocardial infarction will be assessed yearly up to 5 years after index procedure
Measured: 1 year, 2 years, 3 years, 4 years, 5 years
Cardiac death
Cardiac death will be assessed yearly up to 5 years after index procedure
Measured: 1 year, 2 years, 3 years, 4 years, 5 years
All cause mortality
All cause mortality will be assessed yearly up to 5 years after index procedure
Measured: 1 year, 2 years, 3 years, 4 years, 5 years
Target lesion revascularization
Target lesion revascularization will be assessed yearly up to 5 years after index procedure
Measured: 1 year, 2 years, 3 years, 4 years, 5 years
Target vessel revascularization
Target vessel revascularization will be assessed yearly up to 5 years after
Measured: 1 year, 2 years, 3 years, 4 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion1 Oct 2018
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischaemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital Skejby, Aalborg University Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Lisette Okkels Jensen, Odense University Hospital
- Investigators
- Lisette Okkels Jensen, MD DMSci PhD, Study chair, Odense University HospitalEvald H Christiansen, MD PhD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623140
- Sponsor's protocol ID
- SORT OUT IX
- Acronym
- SORT OUT IX
- Status last verified
- Oct 2026
- First submitted
- 30 Nov 2015
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jensen Lisette Okkels, Maeng M, Raungaard B, Kahlert J, Ellert J, Jakobsen L, Villadsen AB, Veien KT, Kristensen SD, Ahlehoff O, Carstensen S, Christensen MK, Terkelsen CJ, Engstroem T, Hansen KN, Botker HE, Aaroe J, Thim T, Thuesen L, Freeman P, Aziz A, Eftekhari A, Junker A, Jensen SE, Lassen JF, Hansen HS, Christiansen EH; Sort Out IX Study Group. Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial. Circulation. 2020 Jun 23;141(25):2052-2063. doi: 10.1161/CIRCULATIONAHA.119.040241. Epub 2020 May 21.
PubMed 32434381Jensen LO, Maeng M, Raungaard B, Engstrom T, Hansen HS, Jensen SE, Botker HE, Kahlert J, Lassen JF, Christiansen EH. Comparison of the polymer-free biolimus-coated BioFreedom stent with the thin-strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population treated with percutaneous coronary intervention: Rationale and design of the randomized SORT OUT IX trial. Am Heart J. 2019 Jul;213:1-7. doi: 10.1016/j.ahj.2019.02.017. Epub 2019 Mar 14.
PubMed 31055192
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02623140
- Acronym / sponsor ID
- SORT OUT IX / SORT OUT IX
- Conditions
- Ischaemic Heart Disease
- Keywords
- Coronary drug eluting stents, Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,150 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital Skejby, Aalborg University Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- Dec 2015
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 7 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofreedom | Experimental | Device: BiofreedomBiofreedom stent treatment at index procedure |
| Orsiro | Active comparator | Device: OrsiroOrsiro stent treatment at index procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiofreedomPCI with Biofreedom stent | Device | Biofreedom |
| OrsiroPCI with Orsiro stent | Device | Orsiro |
Primary outcome
Target Lesion Failure
Time frame: 12 months
Primary endpoint assessed after 12 months
7 secondary outcomes
Target lesion failure
Time frame: 2 year, 3 year, 4 year, 5 year
Stent thrombosis
Time frame: 1 year, 2 years, 3 years, 4 years, 5 years
Myocardial infarction
Time frame: 1 year, 2 years, 3 years, 4 years, 5 years
Cardiac death
Time frame: 1 year, 2 years, 3 years, 4 years, 5 years
All cause mortality
Time frame: 1 year, 2 years, 3 years, 4 years, 5 years
Target lesion revascularization
Time frame: 1 year, 2 years, 3 years, 4 years, 5 years
Target vessel revascularization
Time frame: 1 year, 2 years, 3 years, 4 years, 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Derived from this study: PubMed 32434381Jensen Lisette Okkels, Maeng M, Raungaard B, Kahlert J, Ellert J, Jakobsen L, Villadsen AB, Veien KT, Kristensen SD, Ahlehoff O, Carstensen S, Christensen MK, Terkelsen CJ, Engstroem T, Hansen KN, Botker HE, Aaroe J, Thim T, Thuesen L, Freeman P, Aziz A, Eftekhari A, Junker A, Jensen SE, Lassen JF, Hansen HS, Christiansen EH; Sort Out IX Study Group. Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial. Circulation. 2020 Jun 23;141(25):2052-2063. doi: 10.1161/CIRCULATIONAHA.119.040241. Epub 2020 May 21.
- Derived from this study: PubMed 31055192Jensen LO, Maeng M, Raungaard B, Engstrom T, Hansen HS, Jensen SE, Botker HE, Kahlert J, Lassen JF, Christiansen EH. Comparison of the polymer-free biolimus-coated BioFreedom stent with the thin-strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population treated with percutaneous coronary intervention: Rationale and design of the randomized SORT OUT IX trial. Am Heart J. 2019 Jul;213:1-7. doi: 10.1016/j.ahj.2019.02.017. Epub 2019 Mar 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisette Okkels Jensen, MD DMSci PhD study chair
Odense University Hospital
Evald H Christiansen, MD PhD study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofreedom and Orsiro in people with Ischaemic Heart Disease, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02623140, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.