Comparing imaging techniques for assessing coronary artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of optical coherence tomography (OCT) in measuring the minimal lumen area (MLA) of significant left main coronary stenosis compared to traditional methods like fractional flow reserve (FFR) and computed tomography angiography (CTA). It aims to determine if OCT-derived MLA can provide accurate prognostic information for patients with intermediate coronary stenosis. The study includes patients with specific angiographic criteria and will assess the correlation between these imaging techniques and their implications for patient management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Unprotected LM lesion \[midshaft, and distal bifurcation (Medina 1,1,1 or 1,1,0 or 1,0,1 or 1,0,0)\] of 30% to 80% angiographic diameter stenosis (DS) on visual estimation or equivocal disease by angiography.
* Age ≥18 years.
* Ability to give preliminary oral consent witnessed by an independent physician or sign written informed consent prior to any study-specific procedures.

Exclusion Criteria:

* Significant distal lesions (\>50% angiographic DS on visual estimation within the left anterior descending artery \[LAD\] or left circumflex artery \[LCX\], except for ostium of LAD or LCX or diseased side branch \[e.g. diagonal branch, obtuse marginal branch\])
* Ostial LM disease.
* Acute coronary syndrome (ACS) (non-ST-elevation ACS and ST-elevation MI).
* LM In-stent restenosis.
* Previous coronary stenting of the left coronary system.
* Chronic total occlusion.
* Previous coronary artery bypass graft.
* Previous MI related to the left coronary artery.
* Occurrence of ventricularization or hypotension during engagement of the LM ostial lesion.
* The presence of hemodynamic instability.
* Known renal insufficiency (serum creatinine \>1.5mg/dL or receiving dialysis).
* Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
* Life expectancy less than 1 year.
* Contraindication or known allergy against protocol-required medications including heparin, iodinated contrast, β-blocker, nitroglycerin, and adenosine.
* Body mass index \>35kg/m2.
* Complex congenital heart disease other than anomalous coronary origins alone.
* Ventricular septal defect.

Where it's running

• Centre Hospitalier Universitaire de Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• Institute Mutualiste Montsouris
  Paris, France Recruiting
• Centre Cardiologique du Nord
  Saint-Denis, France Recruiting
• Universitätsklinikum Giessen Justus-Liebig Universität
  Giessen, Hesse, Germany Recruiting
• Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und Angiologie
  Erlangen, Germany Recruiting
• Ageo Central General Hospital
  Ageo, Japan Recruiting

Study contacts

• Principal investigator: Lorenz Raeber, Prof. MD PhD — Inselspital
• Study coordinator: Lorenz Raeber, Prof. MD PhD
• Email: lorenz.raeber@insel.ch
• Phone: +41316322111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.