UnknownNot Applicable

Imaging and Physiology for Intermediate Left Main Stem Stenosis

Brazil53 participantsStarted 2020-06-01

Plain-language summary

The present research aims to determine the impact of stenoses in downstream vessels on the FFR and iFR measurements of left main coronary artery (LMCA) stenoses of intermediate severity as determined by coronary angiography. Anatomic metrics derived from intravascular imaging modalities of IVUS and optical coherence tomography (OCT) will also be validated using as the comparator the FFRtrue and iFRtrue measurements pf LMCA lesions.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- age \>/= 18 years; * patients who have an intermediate (40-70% diameter stenosis) lesion located in the LMS and a concomitant significant (\>/=70% diameter stenosis) in one of the two major downstream vessels (the LAD or the LCx). The severity of LMS and downstream lesions will be assessed by visual estimation of the coronary angiography; * need of complementary diagnostic work up to ascertain the functional/physiological significance of the LMS lesion, that is not possible from the analysis of angiographic images only: * Intermediate severity of LMS lesion, or angiographic ambiguity; * Impossibility to conclusively associate the LMS lesion with the patient's symptoms/clinical presentation due to confounders introduced by the significant downstream lesion; * Impossibility to conclusively determine the severity and functional/physiological significance of the LMS lesion solely by the visual analysis of the coronary angiography; * Impossibility to conclusively determine the relative contribution of the LMS lesion to the ischemic burden determined by non-invasive functional tests due to the presence of a significant downstream lesion; * Clinical indication for PCI of the downstream lesion located in the LAD or LCx: * stable angina unresponsive to optimized medical treatment; * important ischemic burden (\> 10% of myocardial mass in territories supplied by the diseased vessels); * Reduced FFR/iFR values indicative of myocardial ischemia wi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of iFR and FFR values of the LMS stenosis before and after PCI of the significant downstream stenosis

Timeframe: diagnostic procedure

Accuracy of intravascular imaging in predicting functionally signifcant LMS stenosis

Timeframe: diagnostic procedure

Trial details

NCT IDNCT04531007

SponsorInstituto Dante Pazzanese de Cardiologia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-30

Contact for this trial

Daniel Chamie, MD, PhD

+ 55 11 50856345 daniel.chamie@gmail.com

View on ClinicalTrials.gov More Coronary Artery Disease Left Main trials