NCT02093845

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,800 (actual)
• Sponsor: Aarhus University Hospital Skejby · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Biomatrix NeoFlex coronary stent	Percutaneous coronary intervention involving use of stent
DEVICE	SYNERGY stent	Percutaneous coronary intervention involving use of stent

Timeline

• Start date: 2014-02-10
• Primary completion: 2015-08-24
• Completion: 2020-12-31
• First posted: 2014-03-21
• Last updated: 2017-04-25

Locations

3 sites across 1 country: Denmark