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Safety of Negative FrActional Flow Reserve in Patients With ChallEnging Lesions

Safety of Negative FrActional Flow Reserve in Patients With ChallEnging Lesions

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02590926
Acronym
FACE
Enrollment
285
Registered
2015-10-29
Start date
2014-09-26
Completion date
2017-01-01
Last updated
2017-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractional Flow Reserve, Myocardial

Keywords

Fractional Flow Reserve, Myocardial

Brief summary

Fractional Flow Reserve (FFR) has recently emerged and has been largely validated as a safe and efficacious way of ischemia testing for patients with stable angina. The new recently ESC guidelines have strongly suggested a FFR based approach for patients with stable angina, also for those with challenging lesions like left main disease, severe multivessel stenosis for heart failure patients and those with single remaining vessels although left main disease and an ejection fraction less than 30% are exclusion criteria of the randomized controlled trials on this topic. Consequently the investigators performed a prospective multicenter study to understand the safety and efficacy of a FFR based approach for these patients.

Detailed description

The present is a multicenter prospective study enrolling all patients with stable angina and/or documented ischemia presenting with: * An angiographic stenosis of more than 50% and less than 90% of the left main * Any proximal descending anterior with a stenosis of more than 50% and less than 90% * Two or three vessel disease with a stenosis of more than 50% and less than 90% and a left ventricle ejection fraction less than 40% * Single remaining patent coronary artery with stenosis \>50% and less than 90% In all of these patients FFR (Fractional Flow Reserve) will be performed according to guidelines and stenting will be performed or deferred according to the result of this test. Other techniques, like iFR, IVUS and OCT will be left at the operators' choice and will be recorded. MACE (a composite end point of death, myocardial infarction and target vessel revascularization and stent thrombosis) will be the primary end point, while its single components will be the secondary ones.

Interventions

PROCEDUREFractional Flow Reserve, Myocardial

The ratio of maximum blood flow to the myocardium with coronary stenosis present, to the maximum equivalent blood flow without stenosis.

Sponsors

A.O.U. Città della Salute e della Scienza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* An angiographic stenosis of more than 50% and less than 90% of the left main * Any proximal descending anterior with a stenosis of more than 50% and less than 90% * Two or three vessel disease with a stenosis of more than 50% and less than 90% and a left ventricle ejection fraction less than 40% * Single remaining patent coronary artery with stenosis \>50% and less than 90%

Exclusion criteria

* Severe aortic stenosis

Design outcomes

Primary

MeasureTime frameDescription
MACE3 yearscomposite end point of death, myocardial infarctio, target vessel revascularization and target lesion revascularization, stent thrombosis
TVF (only for deferred lesion)1 and 2 yearscomposite of cardiac death,myocardial infarction and target vessel revascularization due to deferred lesion

Secondary

MeasureTime frameDescription
Death1 and 2 yearsand also cardiac death as a separate outcome
TLR1 and 2 years
AMI1 and 2 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026