Safety of Negative FrActional Flow Reserve in Patients With ChallEnging Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

285 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-26

Study Completion Date

2017-01-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Fractional Flow Reserve, Myocardial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

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%

Fractional Flow Reserve, Myocardial

Intervention Type PROCEDURE

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

Interventions

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Fractional Flow Reserve, Myocardial

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

Intervention Type PROCEDURE

Eligibility Criteria

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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%