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

Coronary Artery Disease Clinical Trial

— SORT-OUT VIII  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02093845
• Other study ID #: 1-10-72-3-14
• Status: Active, not recruiting
• Phase: N/A
• First received: February 24, 2014
• Last updated: April 24, 2017
• Start date: February 10, 2014
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2017
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2800
• Est. completion date: December 31, 2020
• Est. primary completion date: August 24, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Biomatrix NeoFlex coronary stent
Percutaneous coronary intervention involving use of stent
• SYNERGY stent
Percutaneous coronary intervention involving use of stent

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital Aalborg	Aalborg
Denmark	Odense University Hospital	Odense
Denmark	Aarhus University Hospital	Skejby	Aarhus N

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Biosensors Europe SA, Boston Scientific Corporation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	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	2, 3, 4 and 5 years
Secondary	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	1, 2, 3, 4 and 5 year
Secondary	Individual above mentioned stent- or patient-related endpoints		1, 2, 3, 4 and 5 years
Secondary	MACE	Combined endpoint as cardiac death, acute myocardial infarction or new revascularisation of the study vessel	1, 2, 3, 4 and 5 years
Secondary	Stent thrombosis	Stent thrombosis according to the Academic Research Consortium definitions	Within 24 hours, between 1 and 30 days, between 30 days and 12 months and after 1, 2, 3, 4 and 5 years
Secondary	Device success rate	The frequency of a successful implantation with residual stenosis <20% of the study stent in all stenoses scheduled to be treated	intraoperative