Coronary Artery DiseaseSORT-OUT VIIINCT02093845

Everolimus-eluting SYNERGY Stent Versus Biolimus-eluting Biomatrix NeoFlex Stent - SORT-OUT VIII

A study testing Biomatrix NeoFlex coronary stent and SYNERGY stent in people with Coronary Artery Disease and Ischemic Heart Disease, run by Aarhus University Hospital Skejby at 3 sites in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this study is to perform a randomised comparison between the SYNERGY and the Biomatrix NeoFlex stents in treatment of unselected patients with ischemic heart disease. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease, Ischemic Heart Disease
What is being tested?: Biomatrix NeoFlex coronary stent and SYNERGY 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: 10 Feb 2014to 31 Dec 2020
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

All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at one of the three heart centers in Odense, Skejby and Aalborg can be included in the study.

Who cannot join

Age < 18 years
The patient does not wish to participate
The patient is not able to consent to randomization (eg intubated patients)
The patient do not live in West Denmark
The patient do not speak Danish
The patient is already included in this study

Show all 12Show fewer

The patient is already participating in other stent studies
Life expectancy <1 year
Allergic to Aspirin, clopidogrel, prasugrel or ticagrelor
Allergic to everolimus or biolimus
Only implanted BMS
Only performed POBA

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites

Aarhus University Hospital Aalborg
Aalborg, 9000
Odense University Hospital
Odense, 5000
Aarhus University Hospital
Skejby, Aarhus N, 8200

Other trials in Denmark

About this study

Official title: Randomized Clinical Comparison of Everolimus-Eluting SYNERGY® and Biolimus-Eluting BioMatrix NeoFlex® Coronary Stents in Non-Selected Patients With Ischemic Heart Disease

The purpose of this study is to perform a randomised comparison between the SYNERGY and the Biomatrix NeoFlex stents in treatment of unselected patients with ischemic heart disease.

Read the detailed description

SORT-OUT VIII is a randomised, multicenter, all-comer, two-arm, non-inferiority trial comparing the everolimus-eluting SYNERGY stent versus the Biomatrix NeoFlex stent in treatment of atherosclerotic coronary artery lesions.

Primary Endpoint:

Device-related Target Lesion Failure (TLF) hierarchically as cardiac death, non-index procedure related acute myocardial infarction (AMI) not clearly related to another lesion than the target lesion, or target lesion revascularisation (TLR) (new revascularization of target lesion) (significant stenosis in the stent ± 5 mm distal/proximal) by percutaneous coronary intervention (PCI) or coronary artery bypass operation (CABG) within 12 months.

Secondary Endpoint:

Device-related target lesion failure hierarchically as cardiac death, non-index procedure related acute myocardial infarction, not clearly related to another lesion than the target lesion, or new target lesion revascularization by percutaneous coronary intervention or coronary bypass operation at 2-5 years.

Patient-related combined endpoint hierarchically as all-cause death, non-index procedure related acute myocardial infarction or all new revascularizations by percutaneous coronary intervention or coronary bypass operation at 12, 24, 36, 48 and 60 months.

Individual above mentioned stent- or patient-related endpoints at 12, 24, 36, 48 and 60 months

MACE (combined endpoint as cardiac death, acute myocardial infarction or new revascularization of the study vessel)

Stent thrombosis defined according to the Academic Research Consortium (ARC) criteria within 24 hours (acute), between 1 and 30 days (subacute), between 30 days and 12 months (late), and after 12, 24, 36, 48 and 60 months (very late).

Device success rate defined as the frequency of a successful implantation with residual stenosis < 20% of the study stent in all the stenoses scheduled to be treated.

Procedural success rate defined as the frequency of successful implantation with residual stenosis <20% of the study stent in all the stenoses scheduled to be treated and without serious complications (cardiac death, non-index procedure related acute myocardial infarction related to target vessel or new revascularization of target lesion by percutaneous coronary intervention or coronary bypass operation).

Inclusion criteria:

All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at one of the three heart centers in Odense, Skejby and Aalborg can be included in the study.

Exclusion criteria Age < 18 years The patient does not wish to participate The patient is not able to consent to randomization (eg intubated patients) The patient do not live in Western Denmark The patient do not speak Danish The patient is already included in this study The patient is participating in other stent studies Life expectancy <1 year Allergic to Aspirin, clopidogrel, prasugrel or ticagrelor Allergic to everolimus or biolimus Only implanted bare metal stents (BMS) Only performed plain old balloon angioplasty (POBA)

Conditions: Coronary Artery Disease, Ischemic Heart Disease
Being tested: Biomatrix NeoFlex coronary stent, SYNERGY stent
Keywords: Percutaneous coronary intervention, DES, Angina pectoris, Stent
Medical subject headings: Coronary Artery Disease, Myocardial Ischemia, Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biomatrix NeoFlex coronary stentDevice
Also called Biolimus-eluting Biomatrix NeoFlex coronary stent
Percutaneous coronary intervention involving use of stent
SYNERGY stentDevice
Also called Everolimus-eluting SYNERGY coronary stent
Percutaneous coronary intervention involving use of stent

Study groups in NCT02093845
Study group	Role	What they receive
SYNERGY	Active comparator	Coronary implantatation of the SYNERGY everolimus-eluting stent Receives: Device: SYNERGY stent
Biomatrix Neoflex	Active comparator	Coronary implantation of the biolimus-eluting Biomatrix NeoFlex stent Receives: Device: Biomatrix NeoFlex coronary stent

What is being measured

The primary outcome is the main question the study is designed to answer.

Device-related target lesion failure
Hierarchically as cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion, or target lesion revascularisation (new revascularisation of target lesion revascularisation (significant stenosis in the stent =/+ 5 mm distal/proximal) by percutaneous coronary intervention or coronary artery bypass operation
Measured: 12 months

Secondary outcomes (6)

Device-related target lesion failure
Hierarchically as cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion, or target lesion revascularisation (new revascularisation of target lesion revascularisation by percutaneous coronary intervention or coronary artery bypass operation
Measured: 2, 3, 4 and 5 years
Patient-related combined endpoint
Hierarchically as all-cause death, non-index procedure related acute myocardial infarction, or all new revascularisation by percutaneous coronary intervention or coronary artery bypass operation
Measured: 1, 2, 3, 4 and 5 year
Individual above mentioned stent- or patient-related endpoints
Measured: 1, 2, 3, 4 and 5 years
MACE
Combined endpoint as cardiac death, acute myocardial infarction or new revascularisation of the study vessel
Measured: 1, 2, 3, 4 and 5 years
Stent thrombosis
Stent thrombosis according to the Academic Research Consortium definitions
Measured: Within 24 hours, between 1 and 30 days, between 30 days and 12 months and after 1, 2, 3, 4 and 5 years
Device success rate
The frequency of a successful implantation with residual stenosis <20% of the study stent in all stenoses scheduled to be treated
Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 201431 Dec 2020

First posted21 Mar 2014 (estimated)
Study start10 Feb 2014
Primary completion24 Aug 2015
Study completion31 Dec 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02093845
Sponsor's protocol ID: 1-10-72-3-14
Acronym: SORT-OUT VIII
Status last verified: Apr 2017
First submitted: 24 Feb 2014
Last updated: 25 Apr 2017
Results posted: No
Data monitoring committee: Yes

Publications

Maeng M, Christiansen EH, Raungaard B, Kahlert J, Terkelsen CJ, Kristensen SD, Carstensen S, Aaroe J, Jensen SE, Villadsen AB, Lassen JF, Thim T, Eftekhari A, Veien KT, Hansen KN, Junker A, Botker HE, Jensen LO; SORT OUT VIII Investigators. Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial). JACC Cardiovasc Interv. 2019 Apr 8;12(7):624-633. doi: 10.1016/j.jcin.2018.12.036.
PubMed 30947936

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Clinical Comparison of Everolimus-Eluting SYNERGY® and Biolimus-Eluting BioMatrix NeoFlex® Coronary Stents in Non-Selected Patients With Ischemic Heart Disease
ClinicalTrials.gov ID: NCT02093845
Acronym / sponsor ID: SORT-OUT VIII / 1-10-72-3-14
Conditions: Coronary Artery Disease, Ischemic Heart Disease
Keywords: Percutaneous coronary intervention, DES, Angina pectoris, Stent
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 2,800 participants (actual)
Lead sponsor: Aarhus University Hospital SkejbyUniversity, hospital or other
Collaborators: Boston Scientific Corporation, Biosensors Europe SA
Study start: 10 Feb 2014 (actual)
Primary completion: 24 Aug 2015 (actual)
Study completion: 31 Dec 2020 (estimated)
First posted: 21 Mar 2014 (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 purpose of this study is to perform a randomised comparison between the SYNERGY and the Biomatrix NeoFlex stents in treatment of unselected patients with ischemic heart disease.

Detailed description

Primary Endpoint:

Secondary Endpoint:

Individual above mentioned stent- or patient-related endpoints at 12, 24, 36, 48 and 60 months

MACE (combined endpoint as cardiac death, acute myocardial infarction or new revascularization of the study vessel)

Device success rate defined as the frequency of a successful implantation with residual stenosis < 20% of the study stent in all the stenoses scheduled to be treated.

Inclusion criteria:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SYNERGY	Active comparator	Device: SYNERGY stentCoronary implantatation of the SYNERGY everolimus-eluting stent
Biomatrix Neoflex	Active comparator	Device: Biomatrix NeoFlex coronary stentCoronary implantation of the biolimus-eluting Biomatrix NeoFlex stent

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at one of the three heart centers in Odense, Skejby and Aalborg can be included in the study.

Key exclusion criteria (12 listed)

Age < 18 years
The patient does not wish to participate
The patient is not able to consent to randomization (eg intubated patients)
The patient do not live in West Denmark
The patient do not speak Danish

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
Biomatrix NeoFlex coronary stentAlso: Biolimus-eluting Biomatrix NeoFlex coronary stentPercutaneous coronary intervention involving use of stent	Device	Biomatrix Neoflex
SYNERGY stentAlso: Everolimus-eluting SYNERGY coronary stentPercutaneous coronary intervention involving use of stent	Device	SYNERGY

Primary outcome

Device-related target lesion failure
Time frame: 12 months
Hierarchically as cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion, or target lesion revascularisation (new revascularisation of target lesion revascularisation (significant stenosis in the stent =/+ 5 mm distal/proximal) by percutaneous coronary intervention or coronary artery bypass operation

6 secondary outcomes

Device-related target lesion failure
Time frame: 2, 3, 4 and 5 years
Patient-related combined endpoint
Time frame: 1, 2, 3, 4 and 5 year
Individual above mentioned stent- or patient-related endpoints
Time frame: 1, 2, 3, 4 and 5 years
MACE
Time frame: 1, 2, 3, 4 and 5 years
Stent thrombosis
Time frame: Within 24 hours, between 1 and 30 days, between 30 days and 12 months and after 1, 2, 3, 4 and 5 years
Device success rate
Time frame: intraoperative

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
Derived from this study: PubMed 30947936Maeng M, Christiansen EH, Raungaard B, Kahlert J, Terkelsen CJ, Kristensen SD, Carstensen S, Aaroe J, Jensen SE, Villadsen AB, Lassen JF, Thim T, Eftekhari A, Veien KT, Hansen KN, Junker A, Botker HE, Jensen LO; SORT OUT VIII Investigators. Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial). JACC Cardiovasc Interv. 2019 Apr 8;12(7):624-633. doi: 10.1016/j.jcin.2018.12.036.

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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.

Michael Maeng, MD principal investigator

Aarhus University Hospital, Skejby, Aarhus N

Evald H Christiansen, MD study chair

Aarhus 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 Biomatrix NeoFlex coronary stent and SYNERGY stent in people with Coronary Artery Disease and Ischemic Heart Disease, 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 12 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: status not confirmed, as of the sponsor's last update on 25 Apr 2017. 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?

Results are not available in the source record.

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 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 NCT02093845, which also lists 1 linked publication.

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 25 Apr 2017.