Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID03820492

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

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2023-02-09

104

Participants Needed

13

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the best way to assess the severity of intermediate narrowing in the left main coronary artery, which is linked to poor outcomes. The study compares three methods: optical coherence tomography (OCT) derived minimal lumen area (MLA), invasive fractional flow reserve (FFR), and noninvasive computed tomography angiography-based FFR (FFRCT). This research aims to find the optimal OCT-MLA cut-off and evaluate FFRCT's diagnostic accuracy against FFR as the reference standard. Participants undergo a multimodality assessment including OCT, invasive FFR, coronary computed tomography angiography (CTA), and FFRCT. OCT is a newer imaging technique with higher resolution than IVUS, while FFR measures blood flow impact on lesions invasively. FFRCT uses computational fluid dynamics to predict blood flow noninvasively from CTA images. The study compares these methods specifically for intermediate left main stenosis to determine their accuracy and usefulness. During the procedure visit, participants receive OCT, FFR, CTA, and FFRCT assessments to measure coronary artery narrowing and blood flow. Researchers collect multiple measurements and compare the results. Clinical outcomes are also followed for one year. This includes monitoring symptoms, imaging, and other clinical endpoints to evaluate the diagnostic methods' predictive value and safety. The total participation timeline includes baseline procedure assessments and a one-year follow-up period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Unprotected left main lesion with 30% to 80% narrowing by angiography
  • Age 18 years or older
  • Ability to give oral or written informed consent before study procedures
Not Eligible

You will not qualify if you...

  • Significant narrowing greater than 50% in the left anterior descending or left circumflex arteries, except for certain side branches
  • Disease affecting the ostial left main artery
  • Acute coronary syndrome or recent heart attack
  • Previous stenting or bypass surgery in the left coronary system
  • Chronic total artery blockage
  • Hemodynamic instability or low blood pressure during procedure
  • Kidney insufficiency with serum creatinine above 1.5 mg/dL or dialysis
  • Women under 50 years old of childbearing potential without permanent sterilization
  • Life expectancy less than 1 year
  • Allergy or contraindication to required medications
  • Body mass index over 35 kg/m2
  • Complex congenital heart disease other than certain coronary anomalies
  • Ventricular septal defect

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo multimodality diagnostic tests including optical coherence tomography, invasive fractional flow reserve, CTA, and FFRCT to assess intermediate left main stenosis.

1 procedure visit (in-person)

Long-term Monitoring

Duration - 12 months

Participants are followed for clinical endpoints to assess outcomes over 1 year after diagnostic evaluation.

Follow-up visits as per standard care over 12 months

Trial Site Locations

Total: 13 locations

1

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, France, 63000

Actively Recruiting

2

Institute Mutualiste Montsouris

Paris, France, 75014

Actively Recruiting

3

Centre Cardiologique du Nord

Saint-Denis, France, 75014

Actively Recruiting

4

Universitätsklinikum Giessen Justus-Liebig Universität

Giessen, Hesse, Germany, 35392

Actively Recruiting

5

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

Erlangen, Germany, 91054

Actively Recruiting

6

Ageo Central General Hospital

Ageo, Japan, 362-8588

Actively Recruiting

7

Gifu heart center

Gifu, Japan, 500-8384

Actively Recruiting

8

Department of Cardiovascular Medicine Shinshu University School of Medicine

Nagano, Japan, 390-8621

Actively Recruiting

9

Kansai Medical University,

Osaka, Japan, 573-1010

Actively Recruiting

10

Medical Corporation Ouyuukai Tokorozawa Heart Center

Saitama, Japan, 359-1142

Actively Recruiting

11

Sapporo Higashi Tokushukai Hospital

Sapporo, Japan, 065-0033

Actively Recruiting

12

Inselspital

Bern, Switzerland, 3010

Actively Recruiting

13

CHUV

Lausanne, Switzerland, 1011

Actively Recruiting

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Research Team

L

Lorenz Raeber, Prof. MD PhD

H

Hiroki Shinutani, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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https://pubmed.ncbi.nlm.nih.gov/15492302

Prospective application of pre-defined intravascular ultrasound criteria for assessment of intermediate left main coronary artery lesions results from the multicenter LITRO study.

Jose M de la Torre Hernandez, Felipe Hernández Hernandez, Fernando Alfonso...

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Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps).

Bjarne L Nørgaard, Jonathon Leipsic, Sara Gaur...

https://pubmed.ncbi.nlm.nih.gov/24486266