The OCT SORT-OUT VIII Study

Aarhus University Hospital Skejby

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Angina Pectoris; Myocardial Infarction

Treatments: Device: Biolimus eluting bioresorbable polymer stent; Device: Everolimus eluting bioresorbable polymer stent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02253108

1-10-72-125-14

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

SYNERGY drug eluting stent

Experimental group

Description:

Everolimus eluting bioresorbable polymer stent

Treatment:

Device: Everolimus eluting bioresorbable polymer stent

Biomatrix NeoFlex drug eluting stent

Experimental group

Description:

Biolimus eluting bioresorbable polymer stent

Treatment:

Device: Biolimus eluting bioresorbable polymer stent