Safety of Negative FrActional Flow Reserve in Patients With ChallEnging Lesions

Fractional Flow Reserve, Myocardial Clinical Trial

— FACE  

Official title:

Safety of Negative FrActional Flow Reserve in Patients With ChallEnging Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590926
• Other study ID #: 370/2015
• Status: Completed
• Phase: N/A
• First received: October 28, 2015
• Last updated: June 1, 2017
• Start date: September 26, 2014
• Est. completion date: January 1, 2017

Study information

• Verified date: June 2017
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: January 1, 2017
• Est. primary completion date: September 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fractional Flow Reserve, Myocardial

Intervention

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.

Locations

Country	Name	City	State
Italy	Fabrizio D'Ascenzo	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Tag — View Citation

De Bruyne B, Fearon WF, Pijls NH, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engström T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nüesch E, Jüni P; — View Citation

Layland J, Oldroyd KG, Curzen N, Sood A, Balachandran K, Das R, Junejo S, Ahmed N, Lee MM, Shaukat A, O'Donnell A, Nam J, Briggs A, Henderson R, McConnachie A, Berry C; FAMOUS–NSTEMI investigators. Fractional flow reserve vs. angiography in guiding manage — View Citation

Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrøm T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators.. Fractional flow reserve versus angiography for guiding percutaneous coronar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	composite end point of death, myocardial infarctio, target vessel revascularization and target lesion revascularization, stent thrombosis	3 years
Primary	TVF (only for deferred lesion)	composite of cardiac death,myocardial infarction and target vessel revascularization due to deferred lesion	1 and 2 years
Secondary	Death	and also cardiac death as a separate outcome	1 and 2 years
Secondary	TLR		1 and 2 years
Secondary	AMI		1 and 2 years