Under construction – not a live service
Sign in
Taking people in GermanyNo phase

Comparing heart imaging and pressure tests for narrowed left main coronary artery

Compares imaging methods with pressure measurement in adults with intermediate left main artery narrowing.

Key facts

Who runs it
Insel Gruppe AG, University Hospital Bern
Where
Erlangen and Giessen, GermanySee the 2 sitesAlso in 3 other countries, 11 sites
Trial code
Registry title
Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT
Status
Recruiting
People taking part
104 people, planned
Started
28 May 2019
Expected to end
31 Dec 2026
Type of study
Interventional
Treatments tested
  • OCT, FFR, CTA and FFRCT
Record updated
9 February 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a left main coronary artery narrowing of intermediate degree, to compare imaging and flow tests of how serious the narrowing is.

Age
18 years or older
Sex
All sexes can join
Disease stage
Unprotected left main artery narrowing of 30% to 80% on the angiogram (by visual estimate), or unclear disease on the angiogram.
Earlier treatment
People with a previous stent in the left coronary system, or previous coronary bypass surgery, cannot join.

Main reasons for not taking part

  • Acute coronary syndrome or heart attack related to the left coronary artery
  • Narrowing right at the start (ostium) of the left main artery
  • Known kidney problems (serum creatinine >1.5mg/dL (133 µmol/L) or dialysis) or body mass index >35kg/m2
  • Life expectancy less than 1 year
  • Women who can still have children (under 50 years with a period in the last 12 months), unless sterilised or surgically treated

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Previous coronary stenting of the left coronary system
  • Previous coronary artery bypass graft
  • Previous MI related to the left coronary artery
  • Ostial LM disease
  • Acute coronary syndrome (ACS) (non-ST-elevation ACS and ST-elevation MI)
  • Contraindication or known allergy against protocol-required medications including heparin, iodinated contrast, β-blocker, nitroglycerin, and adenosine
  • Complex congenital heart disease other than anomalous coronary origins alone
  • 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
  • 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])
  • LM In-stent restenosis
  • Chronic total occlusion
  • Occurrence of ventricularization or hypotension during engagement of the LM ostial lesion
  • The presence of hemodynamic instability
  • Life expectancy less than 1 year
  • Body mass index >35kg/m2
  • Ventricular septal defect

Where in Germany

Also in 3 other countries, 11 sites

  • Friedrich Alexander Universität (FAU) , Medizinische Klinik 2 , Kardiologie und AngiologieErlangen, GermanyContact: Stephan Achenbach, Prof.Taking people
  • Universitätsklinikum Giessen Justus-Liebig UniversitätGiessen, GermanyContact: Nef Holger, ProfessorTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Patient with left-main stenosisOther group

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

    Treatment: OCT, FFR, CTA and FFRCT

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Multimodality Assessment of Intermediate Left Main Stenosis: Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT
Plain-language title
Comparing heart imaging and pressure tests for narrowed left main coronary arteryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
9 February 2023