Clinical trial NCT02590926: Safety of Negative FrActional Flow Reserve in Patients With ChallEnging Lesions
Official title: Safety of Negative FrActional Flow Reserve in Patients With ChallEnging Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractional Flow Reserve, Myocardial
Keywords: Fractional Flow Reserve, Myocardial
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 285
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with stable angina

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.

Eligibility criteria: 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

Primary outcomes:
measure: MACE
timeFrame: 3 years
measure: TVF (only for deferred lesion)
timeFrame: 1 and 2 years
Secondary outcomes:
measure: Death
timeFrame: 1 and 2 years
measure: TLR
timeFrame: 1 and 2 years
measure: AMI
timeFrame: 1 and 2 years
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Fabrizio D'Ascenzo
Study officials:
References:
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citation: Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
citation: Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
citation: Barbero U, D'Ascenzo F, Campo G, Kleczynski P, Dziewierz A, Menozzi M, Jimenez Diaz VA, Cerrato E, Raposeiras-Roubin S, Ielasi A, Rognoni A, Fineschi M, Kanji R, Jaguszewski MJ, Picchi A, Ando G, Soraci E, Mancone M, Sardella G, Calcagno S, Gallo F, Huczek Z, Krakowian M, Verardi R, Montefusco A, Omede P, Lococo M, Moretti C, D'Amico M, Rigattieri S, Gaita F, Rinaldi M, Escaned J. Safety of FFR-guided revascularisation deferral in Anatomically prognostiC diseasE (FACE: CARDIOGROUP V STUDY): A prospective multicentre study. Int J Cardiol. 2018 Nov 1;270:107-112. doi: 10.1016/j.ijcard.2018.06.013. Epub 2018 Jun 8.