NCT02590926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1.9 years

First QC Date

October 28, 2015

Last Update Submit

June 1, 2017

Conditions

Fractional Flow Reserve, Myocardial

Keywords

Fractional Flow Reserve, Myocardial

Outcome Measures

Primary Outcomes (2)

  • MACE

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

    3 years

  • TVF (only for deferred lesion)

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

    1 and 2 years

Secondary Outcomes (3)

  • Death

    1 and 2 years

  • TLR

    1 and 2 years

  • AMI

    1 and 2 years

Study Arms (1)

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

Interventions

Fractional Flow Reserve, MyocardialPROCEDURE

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

Patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with stable angina

You may qualify if:

  • 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%

You may not qualify if:

  • Severe aortic stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fabrizio D'Ascenzo

Turin, 10100, Italy

Location

Related Publications (5)

  • 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 management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS-NSTEMI randomized trial. Eur Heart J. 2015 Jan 7;36(2):100-11. doi: 10.1093/eurheartj/ehu338. Epub 2014 Sep 1.

    PMID: 25179764RESULT

  • 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, Engstrom T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nuesch E, Juni P; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014 Sep 25;371(13):1208-17. doi: 10.1056/NEJMoa1408758. Epub 2014 Sep 1.

    PMID: 25176289RESULT

  • 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.

    PMID: 25173339RESULT

  • 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.

    PMID: 19144937RESULT

  • 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.

    PMID: 29937300DERIVED

MeSH Terms

Interventions

Fractional Flow Reserve, Myocardial

Intervention Hierarchy (Ancestors)

Coronary CirculationBlood CirculationCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Cardiology Cath Lab

Study Record Dates

First Submitted

October 28, 2015

First Posted

October 29, 2015

Study Start

September 26, 2014

Primary Completion

September 5, 2016

Study Completion

January 1, 2017

Last Updated

June 2, 2017

Record last verified: 2017-06

Locations

IT(1)