Safety of Negative FrActional Flow Reserve in Patients With ChallEnging Lesions (FACE)

June 1, 2017 updated by: Claudio Moretti, Azienda Ospedaliera Città della Salute e della Scienza di Torino
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

285

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 10100
        • Fabrizio D'Ascenzo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with stable angina

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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%
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 3 years
composite end point of death, myocardial infarctio, target vessel revascularization and target lesion revascularization, stent thrombosis
3 years
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
1 and 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 1 and 2 years
and also cardiac death as a separate outcome
1 and 2 years
TLR
Time Frame: 1 and 2 years
1 and 2 years
AMI
Time Frame: 1 and 2 years
1 and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 26, 2014

Primary Completion (Actual)

September 5, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Actual)

June 2, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 370/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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