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OpenTrials
Completed

NCT Number: NCT02590926

Safety of Negative FrActional Flow Reserve in Patients With ChallEnging Lesions

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.

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Key information

Conditions

Fractional Flow Reserve, Myocardial

Sex eligibility

All sexes

Study type

Observational

Primary location

Fabrizio D'Ascenzo

Turin, 10100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fractional Flow Reserve, Myocardial

Procedure

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

Primary outcomes

  1. MACE

    Time frame: 3 years

    composite end point of death, myocardial infarctio, target vessel revascularization and target lesion revascularization, stent thrombosis

  2. TVF (only for deferred lesion)

    Time frame: 1 and 2 years

    composite of cardiac death,myocardial infarction and target vessel revascularization due to deferred lesion

Secondary outcomes

  1. Death

    Time frame: 1 and 2 years

    and also cardiac death as a separate outcome

  2. TLR

    Time frame: 1 and 2 years

  3. AMI

    Time frame: 1 and 2 years

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: FACE

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Oct 29, 2015
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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