The OCT SORT-OUT VIII Study

Randomized Comparison of the Biolimus-eluting Biomatrix Neoflex™ og Everolimus-eluting SYNERGY™ Stents in All-comer Patients With Ischemic Heart Disease - The OCT SORT-OUT VIII

The purpose of this study is to compare early vessel healing after implantation of SYNERGY drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts.

Prospective, open label, single blind, randomized study with inclusion of 160 patients in two equal sized cohorts (A and B). Angiographic follow-up with optical coherence tomography (OCT) is performed at 1 month (Cohort A) and 3 months (Cohort B). Randomization 1:1 to SYNERGY or BioMatrix Neoflex. The Cohorts are included consecutively, Cohort A first.

Inclusion Criteria:

• Patients >18 years to be treated with one or more drug-eluting stents in a coronary artery at Aarhus University Hospital or Odense University Hospital

Exclusion Criteria:

• Age <18 years
• Do not wish to participate
• Unable to provide written informed consent
• Domicile outside Denmark
• Do not speak Danish
• Inclusion in the SORT-OUT VIII study
• Inclusion in other stent studies
• Expected survival <1 year
• Allergy to aspirin, clopidogrel, prasugrel or ticagrelor
• Hypersensitivity to everolimus or biolimus
• The operator wishes to use other DES
• Reduced renal function; creatinine> 120 mmol / L
• Only bare metal stent (BMS) implantation
• Only plain old balloon angioplasty (POBA)