Clinical trial NCT02253108: The OCT SORT-OUT VIII Study
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Angina Pectoris
Myocardial Infarction
Keywords: DES
Angina pectoris
Stent
Optical coherence tomography
Stent thrombosis
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Biosensors International
name: Boston Scientific Corporation
First posted: 2014-10-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Coronary Stent Healing Index
timeFrame: 1 or 3 months
measure: Uncovered stent struts
timeFrame: 1 or 3 months
measure: Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts
timeFrame: 1 and 3 months
measure: Persistent malapposition
timeFrame: 1 and 3 months
measure: Neointimal thickness in one frame or lumen mean diameter stenosis
timeFrame: 1 and 3 months
measure: Acquired malapposition
timeFrame: 1 and 3 months
measure: Cumulated extra stent lumen increase in matched cross sectional analysis
timeFrame: 1 and 3 months
Secondary outcomes:
measure: Malapposition
timeFrame: Baseline, 1 and 3 months
measure: Coverage
timeFrame: Baseline, 1 and 3 months
measure: Fracture
timeFrame: Baseline, 1 and 3 months
measure: Neointimal thickness (NIT)
timeFrame: Baseline, 1 and 3 months
measure: Lumen area
timeFrame: Baseline, 1 and 3 months
measure: Stent area
timeFrame: Baseline, 1 and 3 months
measure: Area stenosis (AS) %
timeFrame: Baseline, 1 and 3 months
measure: Minimum expansion of the stent
timeFrame: Baseline, 1 and 3 months
measure: Late recoil
timeFrame: Baseline, 1 and 3 months
measure: Lumen late loss
timeFrame: Baseline, 1 and 3 months
measure: Extra stent lumen
timeFrame: Baseline, 1 and 3 months
measure: Evaginations
timeFrame: Baseline, 1 and 3 months
measure: Thrombus on struts
timeFrame: Baseline, 1 and 3 months
measure: Acute expansion and late recoil
timeFrame: Baseline, 1 and 3 months
measure: Target Lesion Failure (TLF)
timeFrame: Within 12 months
measure: Cardiac death
timeFrame: Baseline, 12, 24, 36, 48 and 60 months
measure: Non-index procedure related acute myocardial infarction (AMI)
timeFrame: Baseline and within 12, 24, 36, 48 and 60 months
measure: Target Lesion Revascularisation (TLR)
timeFrame: Baseline and within 12, 24, 36, 48 and 60 months
measure: All-cause death
timeFrame: 12, 24, 36, 48 and 60 months
measure: Stent thrombosis
timeFrame: Baseline, 1, 12, 24, 36, 48 and 60 months
measure: Device success rate
timeFrame: Baseline
measure: Procedural success rate
timeFrame: Baseline
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Evald H Christiansen, MD
role: PRINCIPAL_INVESTIGATOR
References: