RecruitingNot ApplicableNCT03820492

Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT

Multimodality Assessment of Intermediate Left Main Stenosis: Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

104 participants

Start Date

May 28, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Significant left main (LM) stenosis is associated with a poor prognosis, therefore, adequate judgement of the prognostic significance of LM stenosis is essential to improve patients' prognosis. Recently, fractional flow reserve (FFR) has become widespread practice and carries a Class Ia recommendation to assess functional significance of intermediate coronary stenosis in patients with stable angina. Intravascular ultrasound (IVUS)-derived minimum lumen area (MLA) represents an accurate measure to determine LM significance as shown in multiple studies, while optical coherence tomography (OCT) ,which is a novel intracoronary imaging method with a greater spatial resolution (15μm vs. 100μm), faster image acquisition and facilitated image interpretation, OCT derived-MLA has never been validated against FFR and accordingly, it is not mentioned in the current guidelines for myocardial revascularization. Coronary computed tomography angiography (CTA) has emerged as a noninvasive alternative of coronary angiography with its excellent negative predictive value, while the positive predictive value of CTA is limited. Computational fluid dynamics is an emerging method that enables prediction of blood flow in coronary arteries and calculation of FFR from computed tomography (FFRCT) noninvasively. Noninvasive and accurate assessment of functional significance would bring a great benefit for patients with LM stenosis, however, there are no data to evaluate the diagnostic accuracy of FFRCT for LM stenosis in comparison with FFR and minimal lumen area derived by OCT. This study will investigate the optimal OCT-derived MLA cut-off point and the diagnostic performance of FFRCT for intermediate LM stenosis compared with FFR ≤0.8 as a reference standard.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing three different ways to assess whether a blockage in the left main coronary artery (the main blood vessel supplying the heart's left side) is truly restricting blood flow and requires treatment. The three methods are: OCT (a light-based imaging technique measuring the smallest cross-section of the artery), invasive FFR (a pressure wire technique measuring blood flow across the lesion), and FFRCT (a non-invasive CT-based simulation of FFR). The goal is to determine which method best guides treatment decisions. You may be eligible if: - You are 18 years old or older - You have a left main coronary artery lesion with 30–80% narrowing on angiography - You are able to give consent You may NOT be eligible if: - You have significant narrowing in arteries beyond the left main (LAD or LCX beyond the ostium) - You have ostial left main disease, acute coronary syndrome, or in-stent restenosis - You have had previous bypass surgery, heart stents, or a prior heart attack in the left coronary territory - You have kidney insufficiency (creatinine >1.5mg/dL) - You are a female of childbearing potential who has not been surgically sterilized - Your BMI is greater than 35 kg/m² - You have life expectancy less than 1 year or contraindications to required medications Talk to your interventional cardiologist about your specific coronary anatomy and medication history before enrolling.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTOCT, FFR, CTA and FFRCT

Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT


Locations(13)

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, France

Institute Mutualiste Montsouris

Paris, France

Centre Cardiologique du Nord

Saint-Denis, France

Universitätsklinikum Giessen Justus-Liebig Universität

Giessen, Hesse, Germany

Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie

Erlangen, Germany

Ageo Central General Hospital

Ageo, Japan

Gifu heart center

Gifu, Japan

Department of Cardiovascular Medicine Shinshu University School of Medicine

Nagano, Japan

Kansai Medical University,

Osaka, Japan

Medical Corporation Ouyuukai Tokorozawa Heart Center

Saitama, Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, Japan

Inselspital

Bern, Switzerland

CHUV

Lausanne, Switzerland

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NCT03820492


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