- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02590926
Safety of Negative FrActional Flow Reserve in Patients With ChallEnging Lesions (FACE)
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Turin, Italy, 10100
- Fabrizio D'Ascenzo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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:
|
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
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: N Engl J Med. 2014 Oct 9;371(15):1465.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Fractional Flow Reserve, Myocardial
-
Yonsei UniversityGangnam Severance Hospital; Severance HospitalNot yet recruitingTomography, Optical Coherence | Fractional Flow Reserve, Myocardial
-
University of PatrasCompleted
-
Seoul National University HospitalTerminatedCoronary Angiography | Fractional Flow Reserve, Myocardial | Drug-eluting StentsKorea, Republic of
-
Semmelweis University Heart and Vascular CenterBajcsy-Zsilinszky HospitalUnknown
-
Catharina Ziekenhuis EindhovenCompletedCoronary Artery Disease | Fractional Flow Reserve | Absolute Flow Measurement | FFR-CT | Myocardial MassNetherlands
-
Timothy M. Bateman, MDCompletedMyocardial Blood Flow ReserveUnited States
-
Centro Hospitalar Lisboa OcidentalAbbott Medical Devices; Cardiovascular Research Foundation, New YorkUnknownCoronary Artery Disease | Fractional Flow Reserve, MyocardialUnited States, France, Italy, Portugal
-
Contilia Clinical Research InstituteUnknownCoronary Artery Disease | Fractional Flow Reserve, MyocardialGermany
-
Centre Recherche Cardio Vasculaire AlpesCompletedFractional Flow Reserve | Coronary Artery StenosisFrance
-
Henan Institute of Cardiovascular EpidemiologyRecruitingCoronary Artery Disease | Coronary Angiography | Fractional Flow Reserve, MyocardialChina
Clinical Trials on Fractional Flow Reserve, Myocardial
-
Peking University First HospitalRainmed Ltd., Suzhou, ChinaRecruitingCoronary Artery Disease | Percutaneous Coronary Intervention | Stable Angina Pectoris | Unstable Angina Pectoris | Coronary Stenosis | Acute Myocardial Infarction | Myocardial Ischaemia | Coronary Circulation | Asymptomatic IschemiaChina
-
University Hospital of FerraraSocietà Italiana di Cardiologia InvasivaCompleted
-
Volcano CorporationCompletedCoronary DiseaseBelgium
-
The Catholic University of KoreaActive, not recruiting
-
University of GlasgowWithdrawnCoronary Artery Disease | Coronary Artery Bypass Surgery | Fracational Flow Reserve
-
Clinyx, LLCVolcano CorporationCompletedCoronary Artery Disease
-
University Hospital of FerraraCompleted
-
Ottawa Heart Institute Research CorporationActive, not recruitingHeart DiseaseCanada, Belgium
-
University of Erlangen-Nürnberg Medical SchoolAbbott Medical DevicesUnknown
-
Seoul National University HospitalUlsan University Hospital; Seoul National University Bundang Hospital; Inje University and other collaboratorsRecruitingCoronary Artery DiseaseKorea, Republic of