Vessel Imaging Using Optical Coherence Tomography for Plaque Morphology and Vessel Fractional Flow Reserve

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Warsaw

About this trial

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 index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Acute coronary syndrome

Proximal left main lesion

Ostial right coronary artery lesion

Bypass of the assessed vessel

Trial population

Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • vessel Fractional Flow Reserve

    Diagnostic test

    Optical coherence tomography and vessel fractional flow reserve evaluation of coronary arteries with intermediate to severe stenosis.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients undergoing coronary angiogram in chronic coronary syndrome with intermediate stenosis.1 intervention

Trial outcomes

Primary outcomes

1

Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis

Correlation between vessel fractional flow reserve (FFR) and minimal lumen area within the coronary stenosis

Time frame
0 days

Secondary outcomes

1

Major adverse cardiovascular events

Major adverse cardiovascular events

Time frame
36 months

Other outcomes

Sponsors and contacts

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