Coronary Artery DiseaseSO VINCT01956448
SORT-OUT VI - Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity®
A study testing Drug eluting stent in people with Coronary Artery Disease and Angina Pectoris, run by Aarhus University Hospital Skejby at 3 sites in Denmark.
Trial summary
To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity® stents in the treatment of unselected patients with ischemic heart disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris
- What is being tested?
- Drug eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,800 participants
- Where
- 3 sitesDenmark
- Study dates
- Mar 2011to Jul 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, 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, prasugrel, sirolimus, or biolimus
- participation in another randomized trial
- inability to provide written informed consent
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aalborg University Hospital
Aalborg, 9000
Odense University Hospital
Odense, 5000
Aarhus University Hospital
Skejby, Aarhus N, 8200
About this study
Official title: Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity® Coronary Stents in Non-selected Patients With Ischemic Heart Disease The SORT OUT VI Study*
To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity® stents in the treatment of unselected patients with ischemic heart disease.
Read the detailed description
SORT OUT VI is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the Biolimus-eluting Biomatrix Flex and the Zotarolimus-eluting Medtronic Resolute Integrity in treatment of atherosclerotic coronary artery lesions.
Primary Endpoint:
Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization).
Secondary Endpoints:
Individual components of the primary end point comprised the secondary end points and stent thrombosis rate according to the Academic Research Consortium definition (see protocol for further specification of secondary endpoints).
Clinically driven event detection will be used to avoid study-induced reinterventions. Data on mortality, hospital admission, coronary angiography, repeat percutaneous coronary intervention, and coronary bypass surgery will be obtained for all randomly allocated patients from the following national Danish administrative and healthcare registries: the Civil Registration System; the Western Denmark Heart Registry; the Danish National Registry of Patients, which maintains records on all hospitalizations in Denmark; and the Danish Registry of Causes of Death
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Being tested
- Drug eluting stent
- Keywords
- Percutaneous coronary intervention, DES, Angina pectoris, Stent
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug eluting stentDevice
Also called BioMatrix Flex - biolimus eluting stent, Resolute - zotarolimus eluting stent
Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)
| Study group | Role | What they receive |
|---|---|---|
| Drug eluting stent (BioMatrix Flex) | Experimental | Device: Percutaneous coronary intervention with implantation of drug eluting stent (BioMatrix Flex) Receives: Device: Drug eluting stent |
| Drug eluting stent (Resolute Integrity) | Experimental | Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity) Receives: Device: Drug eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related combined endpoint
Device-related combined endpoint hierarchically:
cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion (new revascularization by PCI or CABG) within 12 months.
Measured: 1,2,3 and 5 years
Secondary outcomes (12)
Device success rate
Measured: 12 months
Procedure success rate
Measured: 12 months
Procedure time
Measured: 12 months
Fluoroscopy time
Measured: 12 months
Amount of contrast
Measured: 12 months
Combined endpoint of cardiac death, non-index procedure related acute myocardial infarction, not clearly related to another lesion than target lesion, target lesion revascularisation
Measured: 30 days
Target lesion revascularisation
Measured: 1,2,3 and 5 years
Death and myocardial infarction
Measured: 1 and 12 months
Stent thrombosis
Measured: 1,2,3 and 5 years
Device-related combined endpoint hierarchically cardiac death, non-index procedure related AMI, not clearly related to another lesion than target lesion
Measured: 2,3 and 5 years
Patient-related combined endpoint hierarchically: all-cause death, non-index procedure related acute myocardial infarction, all new revascularizations
Measured: 1,2,3 and 5 years
All-cause death
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startMar 2011
- Primary completionJul 2012
- Study completionJul 2012
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 Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 2,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Biosensors International, Medtronic Cardiovascular
- Responsible party
- Principal investigator, Evald Hoej Christiansen, Aarhus University Hospital Skejby
- Investigators
- Jan Ravkilde, MD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956448
- Sponsor's protocol ID
- M-20110037
- Acronym
- SO VI
- Status last verified
- Oct 2013
- First submitted
- 4 Jun 2012
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Raungaard B, Christiansen EH, Botker HE, Hansen HS, Ravkilde J, Thuesen L, Aaroe J, Villadsen AB, Terkelsen CJ, Krusell LR, Maeng M, Kristensen SD, Veien KT, Hansen KN, Junker A, Madsen M, Andersen SL, Jensen SE, Jensen LO; SORT OUT VI Investigators. Comparison of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: 3-Year Clinical Outcomes in the Randomized SORT OUT VI Trial. JACC Cardiovasc Interv. 2017 Feb 13;10(3):255-264. doi: 10.1016/j.jcin.2016.11.007. Epub 2017 Jan 18.
PubMed 28109874Raungaard B, Jensen LO, Tilsted HH, Christiansen EH, Maeng M, Terkelsen CJ, Krusell LR, Kaltoft A, Kristensen SD, Botker HE, Thuesen L, Aaroe J, Jensen SE, Villadsen AB, Thayssen P, Veien KT, Hansen KN, Junker A, Madsen M, Ravkilde J, Lassen JF; Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT). Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial. Lancet. 2015 Apr 18;385(9977):1527-35. doi: 10.1016/S0140-6736(14)61794-3. Epub 2015 Jan 16.
PubMed 25601789
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity® Coronary Stents in Non-selected Patients With Ischemic Heart Disease The SORT OUT VI Study*
- ClinicalTrials.gov ID
- NCT01956448
- Acronym / sponsor ID
- SO VI / M-20110037
- Conditions
- Coronary Artery Disease, Angina Pectoris
- Keywords
- Percutaneous coronary intervention, DES, Angina pectoris, Stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,800 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Biosensors International, Medtronic Cardiovascular
- Study start
- Mar 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Oct 2013 (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.
To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity® stents in the treatment of unselected patients with ischemic heart disease.
Detailed description
SORT OUT VI is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the Biolimus-eluting Biomatrix Flex and the Zotarolimus-eluting Medtronic Resolute Integrity in treatment of atherosclerotic coronary artery lesions.
Primary Endpoint:
Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization).
Secondary Endpoints:
Individual components of the primary end point comprised the secondary end points and stent thrombosis rate according to the Academic Research Consortium definition (see protocol for further specification of secondary endpoints).
Clinically driven event detection will be used to avoid study-induced reinterventions. Data on mortality, hospital admission, coronary angiography, repeat percutaneous coronary intervention, and coronary bypass surgery will be obtained for all randomly allocated patients from the following national Danish administrative and healthcare registries: the Civil Registration System; the Western Denmark Heart Registry; the Danish National Registry of Patients, which maintains records on all hospitalizations in Denmark; and the Danish Registry of Causes of Death
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug eluting stent (BioMatrix Flex) | Experimental | Device: Drug eluting stentDevice: Percutaneous coronary intervention with implantation of drug eluting stent (BioMatrix Flex) |
| Drug eluting stent (Resolute Integrity) | Experimental | Device: Drug eluting stentDevice: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 (4 listed)
- life expectancy of less than one year
- an allergy to aspirin, clopidogrel, ticagrelor, prasugrel, sirolimus, or biolimus
- participation in another randomized trial
- 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 |
|---|---|---|
| Drug eluting stentAlso: BioMatrix Flex - biolimus eluting stent, Resolute - zotarolimus eluting stentDevice: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity) | Device | Drug eluting stent (BioMatrix Flex), Drug eluting stent (Resolute Integrity) |
Primary outcome
Device-related combined endpoint
Time frame: 1,2,3 and 5 years
Device-related combined endpoint hierarchically: cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion (new revascularization by PCI or CABG) within 12 months.
12 secondary outcomes
Device success rate
Time frame: 12 months
Procedure success rate
Time frame: 12 months
Procedure time
Time frame: 12 months
Fluoroscopy time
Time frame: 12 months
Amount of contrast
Time frame: 12 months
Combined endpoint of cardiac death, non-index procedure related acute myocardial infarction, not clearly related to another lesion than target lesion, target lesion revascularisation
Time frame: 30 days
Target lesion revascularisation
Time frame: 1,2,3 and 5 years
Death and myocardial infarction
Time frame: 1 and 12 months
Stent thrombosis
Time frame: 1,2,3 and 5 years
Device-related combined endpoint hierarchically cardiac death, non-index procedure related AMI, not clearly related to another lesion than target lesion
Time frame: 2,3 and 5 years
Patient-related combined endpoint hierarchically: all-cause death, non-index procedure related acute myocardial infarction, all new revascularizations
Time frame: 1,2,3 and 5 years
All-cause death
Time frame: 10 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 8 Oct 2013.
- Derived from this study: PubMed 28109874Raungaard B, Christiansen EH, Botker HE, Hansen HS, Ravkilde J, Thuesen L, Aaroe J, Villadsen AB, Terkelsen CJ, Krusell LR, Maeng M, Kristensen SD, Veien KT, Hansen KN, Junker A, Madsen M, Andersen SL, Jensen SE, Jensen LO; SORT OUT VI Investigators. Comparison of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: 3-Year Clinical Outcomes in the Randomized SORT OUT VI Trial. JACC Cardiovasc Interv. 2017 Feb 13;10(3):255-264. doi: 10.1016/j.jcin.2016.11.007. Epub 2017 Jan 18.
- Derived from this study: PubMed 25601789Raungaard B, Jensen LO, Tilsted HH, Christiansen EH, Maeng M, Terkelsen CJ, Krusell LR, Kaltoft A, Kristensen SD, Botker HE, Thuesen L, Aaroe J, Jensen SE, Villadsen AB, Thayssen P, Veien KT, Hansen KN, Junker A, Madsen M, Ravkilde J, Lassen JF; Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT). Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial. Lancet. 2015 Apr 18;385(9977):1527-35. doi: 10.1016/S0140-6736(14)61794-3. Epub 2015 Jan 16.
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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.
Jan Ravkilde, MD principal investigator
Aalborg University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug eluting stent in people with Coronary Artery Disease and Angina Pectoris, run by Aarhus University Hospital Skejby at 3 sites 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 4 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 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Device-related combined endpoint (time frame: 1,2,3 and 5 years). 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 NCT01956448, 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 8 Oct 2013.