Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coron… (NCT03767621) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR
Spain300 participantsStarted 2019-02-19
Plain-language summary
The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations.
Studies with a limited number of patients have shown that a value of FFR (Fractional Flow Reserve) above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.
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:
* Patients with intermediate lesion in the LMCA (25-60% angiographic stenosis) by visual estimation) in which the realization of a study with guide of pressure for the determination of the iFR.
* Patients aged ≥18 years.
* Patients able of giving informed consent.
Exclusion Criteria:
* Patients with indication for coronary surgery regardless of the significance of the LMCA lesion.
* Patients with a LMCA lesion presenting with ulceration, dissection or thrombus.
* Patients with previous arterial or venous graft lesion functioning in the territory irrigated by the LMCA (LMCA protected).
* Patients with ACS (Acute Coronary Syndrome) with a potentially guilty lesion in the LMCA.
* Patients unable to obtain informed consent.
* Patients with known terminal illness that conditions a life expectancy less than 1 year.
* Patients with hemodynamic instability with Killip III or IV class.
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
1
Assessment correlation between FFR>=0.80 and iFR >=0.89