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

NCT ID: NCT02093845

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-10
• Study Completion Date: 2020-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SYNERGY

Coronary implantatation of the SYNERGY everolimus-eluting stent

Group Type: ACTIVE_COMPARATOR

SYNERGY stent

Intervention Type: DEVICE

Percutaneous coronary intervention involving use of stent

Biomatrix Neoflex

Coronary implantation of the biolimus-eluting Biomatrix NeoFlex stent

Group Type: ACTIVE_COMPARATOR

Biomatrix NeoFlex coronary stent

Intervention Type: DEVICE

Percutaneous coronary intervention involving use of stent

Interventions

Biomatrix NeoFlex coronary stent

Percutaneous coronary intervention involving use of stent

Intervention Type: DEVICE

SYNERGY stent

Percutaneous coronary intervention involving use of stent

Intervention Type: DEVICE

Other Intervention Names

Biolimus-eluting Biomatrix NeoFlex coronary stent; Everolimus-eluting SYNERGY coronary stent

Eligibility Criteria

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 West Denmark
• The patient do not speak Danish
• The patient is already included in this study
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Biosensors Europe SA

INDUSTRY

Sponsor Role: collaborator

Aarhus University Hospital Skejby

OTHER

Sponsor Role: lead

Responsible Party

Michael Mæng

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Maeng, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital, Skejby, Aarhus N

Evald H Christiansen, MD

Role: STUDY_CHAIR

Aarhus University Hospital

Locations

Aarhus University Hospital

Skejby, Aarhus N, Denmark

Aarhus University Hospital Aalborg

Aalborg, , Denmark

Odense University Hospital

Odense, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 30947936 (View on PubMed)

Other Identifiers

1-10-72-3-14

Identifier Type: -

Identifier Source: org_study_id