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Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractio

The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between mopphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma and a functional

Condition(s)Coronary Artery Disease, Coronary Artery Stenosis, Tomography, Optical Coherence, 3D-angio-based FFR
StatusRecruiting
Study typeObservational
SummaryThe aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between mopphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.
Who can participateInclusion Criteria: * 18 years or older * Chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the Canadian Cardiovascular Society classification or positive ischemia test (exercise test, single photon emission tomography (SPECT) * Intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography and OCT examination The patient is willing to participate in the study and has provided a written informed consent Exclusion Criteria: * Acute coronary syndrome * Proximal left main lesion * Ostial right coronary artery lesion * Bypass of the assessed vessel * Contraindications for adenosine administration * Hemodynamic instability * Heart insufficiency in New York Heart Association (NYHA) class IV scale * Acute renal insufficiency * Pregnancy
Ages18 Years
SexAll
Lead sponsorMedical University of Warsaw
LocationsWarsaw, Mazowieckie Voivodenship, Poland
Start date2020-09-20
NCT IDNCT06844942
Official listinghttps://clinicaltrials.gov/study/NCT06844942

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