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Clinical Trials in Denmark / NCT02253108
Active, not recruiting Not applicable

The OCT SORT-OUT VIII Study

NCT02253108 · tracked via the Priya Life Science Denmark tracker
Sponsor
Aarhus University Hospital Skejby
Phase
Not applicable
Started
2014-05
Last updated
2026-01-02

Condition(s) studied

Coronary Artery DiseaseAngina PectorisMyocardial Infarction

Investigational drug(s) / intervention(s)

Everolimus eluting bioresorbable polymer stentBiolimus eluting bioresorbable polymer stent

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Coronary Stent Healing Index — 1 or 3 months
    Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT)
  • Uncovered stent struts — 1 or 3 months
    Uncovered stent struts 2%=1, 5%=2, 10%=3, 15%=4, 20%=5, 25%=6, 30%=7, 35%=8, 40%=9
  • Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts — 1 and 3 months
    Uncovered stent struts in front of side branchs (SB), on acquired or persistent malapposed struts10%=1, 20%=2, 30%=3 etc to 100%=0
  • Persistent malapposition — 1 and 3 months
    Persistent malapposition: \>2 adjacent struts of at least 1 mm length =1; \>2 mm=2; \>3 mm=3
  • Neointimal thickness in one frame or lumen mean diameter stenosis — 1 and 3 months
    Neointimal thickness in one frame or lumen mean diameter stenosis \>200=1; \>300=2; \>400=3 or diameter stenosis \>50%=4; \>75%=5
  • Acquired malapposition — 1 and 3 months
    Acquired malapposition: \>2 adjacent struts of at least 1 mm length =2; \> 2 mm=4; \> 3 mm=6
  • Cumulated extra stent lumen increase in matched cross sectional analysis — 1 and 3 months
    Cumulated extra stent lumen increase in matched cross sectional analysis (measurement mean area)

Trial sites (2)

FacilityCityRegionStatus
Aarhus University Hospital, Skejby Aarhus Denmark
Odense University Hospital Odense Denmark

More Aarhus University Hospital Skejby trials in Denmark

The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER) Active, not recruiting
ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO Recruiting
The Bioresorbable Implants for Scaffolding Obstructions in Randomized Bifurcations (BIFSORB) Study Active, not recruiting
Optical Coherence Tomography in Acute Vessel Evaluation Enrolling by invitation
SORT OUT X - Combo Stent Versus ORSIRO Stent Active, not recruiting

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The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease Recruiting
Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation Active, not recruiting
Quality of Life After Transcatheter Aortic Valve Implantation Active, not recruiting
VIsualization of Coronary Artery Disease for Modification of RISK Factors Active, not recruiting
Electronic Letters to Improve Patient Activation in IHD: The NUDGE-IHD Trial Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02253108 on ClinicalTrials.gov ↗ ← All trials in Denmark