Correlations between fractional flow reserve and intravascular ultrasound in patients with an ambiguous left main coronary artery stenosis.
Venu Jasti, Eugen Ivan, Venkata Yalamanchili...
https://pubmed.ncbi.nlm.nih.gov/15492302/Actively Recruiting
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2023-02-09
104
Participants Needed
13
Research Sites
N/A
Total Duration
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 FFRCTs 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
Comparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT
L
Lorenz Raeber, Prof. MD PhD
H
Hiroki Shinutani, MD
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Insel Gruppe AG, University Hospital Bern
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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/30165437/Insel Gruppe AG, University Hospital Bern
Lead Sponsor