Overview

This trial is active, not recruiting.

Conditions coronary artery disease, angina pectoris, myocardial infarction
Treatments everolimus eluting bioresorbable polymer stent, biolimus eluting bioresorbable polymer stent
Sponsor Aarhus University Hospital Skejby
Collaborator Biosensors International
Start date May 2014
End date April 2015
Trial size 160 participants
Trial identifier NCT02253108, 1-10-72-125-14

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Everolimus eluting bioresorbable polymer stent
everolimus eluting bioresorbable polymer stent SYNERGY
(Experimental)
Biolimus eluting bioresorbable polymer stent
biolimus eluting bioresorbable polymer stent Biomatrix NeoFlex

Primary Outcomes

Measure
Coronary Stent Healing Index
time frame: 1 or 3 months
Uncovered stent struts
time frame: 1 or 3 months
Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts
time frame: 1 and 3 months
Persistent malapposition
time frame: 1 and 3 months
Neointimal thickness in one frame or lumen mean diameter stenosis
time frame: 1 and 3 months
Acquired malapposition
time frame: 1 and 3 months
Cumulated extra stent lumen increase in matched cross sectional analysis
time frame: 1 and 3 months

Secondary Outcomes

Measure
Malapposition
time frame: Baseline, 1 and 3 months
Coverage
time frame: Baseline, 1 and 3 months
Fracture
time frame: Baseline, 1 and 3 months
Neointimal thickness (NIT)
time frame: Baseline, 1 and 3 months
Lumen area
time frame: Baseline, 1 and 3 months
Stent area
time frame: Baseline, 1 and 3 months
Area stenosis (AS) %
time frame: Baseline, 1 and 3 months
Minimum expansion of the stent
time frame: Baseline, 1 and 3 months
Late recoil
time frame: Baseline, 1 and 3 months
Lumen late loss
time frame: Baseline, 1 and 3 months
Extra stent lumen
time frame: Baseline, 1 and 3 months
Evaginations
time frame: Baseline, 1 and 3 months
Thrombus on struts
time frame: Baseline, 1 and 3 months
Acute expansion and late recoil
time frame: Baseline, 1 and 3 months
Target Lesion Failure (TLF)
time frame: Within 12 months
Cardiac death
time frame: Baseline, 12, 24, 36, 48 and 60 months
Non-index procedure related acute myocardial infarction (AMI)
time frame: Baseline and within 12, 24, 36, 48 and 60 months
Target Lesion Revascularisation (TLR)
time frame: Baseline and within 12, 24, 36, 48 and 60 months
All-cause death
time frame: 12, 24, 36, 48 and 60 months
Stent thrombosis
time frame: Baseline, 1, 12, 24, 36, 48 and 60 months
Device success rate
time frame: Baseline
Procedural success rate
time frame: Baseline

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title 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
Principal investigator Evald H Christiansen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Aarhus University Hospital Skejby.