The OCT SORT-OUT VIII Study

N/AActive Not RecruitingNCT02253108

Aarhus University Hospital Skejby160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Coronary Artery Disease Angina Pectoris Myocardial Infarction

Interventions

Everolimus eluting bioresorbable polymer stentDEVICE

Biolimus eluting bioresorbable polymer stentDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Aarhus University Hospital, Skejby

Aarhus, Denmark

Odense University Hospital

Odense, Denmark

Outcomes

Primary Outcomes

Coronary Stent Healing Index

Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT)

Time frame: 1 or 3 months

Uncovered stent struts

Uncovered stent struts 2%=1, 5%=2, 10%=3, 15%=4, 20%=5, 25%=6, 30%=7, 35%=8, 40%=9

Time frame: 1 or 3 months

Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts

Uncovered stent struts in front of side branchs (SB), on acquired or persistent malapposed struts10%=1, 20%=2, 30%=3 etc to 100%=0

Time frame: 1 and 3 months

Persistent malapposition

Persistent malapposition: \>2 adjacent struts of at least 1 mm length =1; \>2 mm=2; \>3 mm=3

Time frame: 1 and 3 months

Neointimal thickness in one frame or lumen mean diameter stenosis

Neointimal thickness in one frame or lumen mean diameter stenosis \>200=1; \>300=2; \>400=3 or diameter stenosis \>50%=4; \>75%=5

Time frame: 1 and 3 months

Acquired malapposition

Acquired malapposition: \>2 adjacent struts of at least 1 mm length =2; \> 2 mm=4; \> 3 mm=6

Time frame: 1 and 3 months

Cumulated extra stent lumen increase in matched cross sectional analysis

Cumulated extra stent lumen increase in matched cross sectional analysis (measurement mean area)

Time frame: 1 and 3 months

Secondary Outcomes

Data from ClinicalTrials.gov

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Detectable separation between the vessel wall and strut in a cross section.