Angio-based Fractional Flow Reserve to Predict Adverse Events After Stent Implantation (HAWKEYE)

• ClinicalTrials.gov Identifier: NCT02811796
• Recruitment Status: Active, not recruiting
• First Posted: June 23, 2016
• Last Update Posted: January 7, 2019
• Sponsor: University Hospital of Ferrara
• Information provided by (Responsible Party): Gianluca Campo, University Hospital of Ferrara

Study Description

Brief Summary:

The investigators will collect prospectively baseline, procedural and follow-up data of all patients receiving successful percutaneous coronary intervention (PCI) and stent implantation. Angio-based flow fractional reserve (quantitative flow ratio, QFR, Medis medical imaging systems Leiden, The Netherlands) will be estimated in all patients. Especially, the investigators at the end of the procedure (this is defined according operator's judgement) will record 2 orthogonal angiograms (as suggested by QFR instructions) at 15 frames/second and the same 2 orthogonal angiograms at 30 frames/second. An independent corelab (blinded to procedural data and clinical outcome) will estimate QFR value (one with the angiograms at 15 frames and one with those at 30 frames

Condition or disease	Intervention/treatment
Prognosis; Stents	Other: angio-based FFR estimation

Detailed Description:

Fractional flow reserve (FFR) allows to evaluate the functional significance of coronary artery lesions, through the ratio of the mean coronary artery pressure after the stenosis to the mean aortic pressure during maximum hyperaemia. The actual widely accepted cutoff value is 0.80. Below this value, an intermediate coronary lesion is considered significant and its treatment with percutaneous coronary intervention (PCI) is justified.

The measurement FFR after stent implantation has a strong predictive value with respect to death, myocardial infarction, or need for repeat revascularization of the target vessel within 6 months. The higher the FFR, the lower the event rate. FFR cut-off of 0.90 might be a useful indicator in daily practice for optimal physiologic stent implantation. Nevertheless, the use of the FFR in the post stenting , is relatively low, because of costs of the pressure wire and the adverse effects related to the use of adenosine.

A new method (QFR by Medis medical imaging) for evaluation of the functional significance of coronary stenosis is based on computer calculation of the FFR value. This calculation is performed by analysing the coronary angiogram and thus reduces or potentially eliminates the need for measuring FFR by pressure wires. The QFR method combines a 3D reconstructions of the target vessel based on two angiographic projections and the contrast flow velocity to compute the "FFR value". To perform QFR the investigators will acquire two angiographic projections with angle >25 degree that allow the 3D reconstruction of the vessel (see values below).

Projections for left main (LM) and proximal left anterior descending (LAD) or proximal left circumflex (LCX): right anterior oblique (RAO) 20, Caudal 45 and anterior-posterior (AP), Caudal 10

Projections for LAD/diagonal: AP, Cranial 45 and RAO 35, Cranial 20

Projections for LCX/obtuse marginal (OM): left anterior oblique (LAO) 10, Caudal 45 and RAO 25, Caudal 25

Projections for Proximal+Mid right coronary artery (RCA): LAO 45, caudal (CAUD) 0 and AP, CAUD 0

Projections for postero-lateral artery and posterior-descending artery (PLA/PDA): LAO 45, CAUD 0 and LAO 30, CAUD 30

Finally, the investigators will assess the relationship between QFR value and adverse events. We will assess the best QFR value able to discriminate the cumulative occurrence of adverse events. In the study, we will include also ST-segment elevation myocardial infarction patients. This subset of patients will be analysed as independent cohort to obtain preliminary results and will be analysed in a independent study

Study Design

• Study Type: Observational
• Actual Enrollment: 602 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Validation of the Angio-based Fractional Flow Reserve (Quantitative Flow Ratio, QFR) System to Discriminate Patients at Risk of Adverse Events After Stent Implantation.
• Actual Study Start Date: June 2016
• Actual Primary Completion Date: July 2018
• Estimated Study Completion Date: July 2022

Groups and Cohorts

Group/Cohort

Intervention/treatment

angio-based FFR estimation; The investigators will include all patients receiving successful coronary stent implantation. In these patients the investigators will acquire specific angiograms to permit angio-based FFR (QFR) calculation. An independent corelab will estimate the QFR value. This value will be related to prognosis to verify if it is able to discriminate those at higher risk of adverse events.

Other: angio-based FFR estimation; The investigators will acquire specific angiograms to permit angio-based FFR (QFR) calculation. An independent corelab will estimate the QFR value. This value will be related to prognosis to verify if it is able to discriminate those at higher risk of adverse events.

Outcome Measures

Primary Outcome Measures :

1. Device-oriented cardiac events [ Time Frame: 1-year ]
   cumulative occurrence of cardiac death, target vessel myocardial infarction, target lesion revascularization

Secondary Outcome Measures :

1. cardiac death [ Time Frame: 1-year ]
   cumulative occurrence of cardiac death
2. all-cause mortality [ Time Frame: 1-year ]
   cumulative occurrence of all-cause mortality
3. any myocardial infarction [ Time Frame: 1-year ]
   cumulative occurrence of any myocardial infarction
4. target vessel revascularization [ Time Frame: 1-year ]
   cumulative occurrence of target vessel revascularization
5. stent thrombosis [ Time Frame: 1-year ]
   cumulative occurrence of definite, probable and possible stent thrombosis
6. hospital admission for all causes [ Time Frame: 1-year ]
   cumulative occurrence of hospital admission for all causes

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Subjects receiving complete revascularization with successful PCI and stent implantation (second generation drug eluting stent)

Criteria

Inclusion Criteria:

-successfull percutaneous coronary intervention and stent implantation

Exclusion Criteria:

• inability to provide consent
• inability to guarantee at least 1-year follow-up
• thrombolysis in myocardial infarction (TIMI) flow <3
• life expectancy <1 year
• previous coronary artery bypass graft
• atrial fibrillation
• ongoing ventricular arrhythmias
• significant and persistent tachycardia (heart rate >100 bpm)

Contacts and Locations

Locations

Italy

University Hospital of Ferrara

Cona, Ferrara, Italy, 44124

ASP Agrigento

Agrigento, Italy

Ospedale Civile

Agrigento, Italy

Caserta, Italy

San Luigi Gonzaga

Orbassano, Italy

Ospedale Civile

Seriate, Italy

Spain

Hospital Clinic

Barcellona, Spain

Sponsors and Collaborators

University Hospital of Ferrara

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Biscaglia S, Tebaldi M, Brugaletta S, Cerrato E, Erriquez A, Passarini G, Ielasi A, Spitaleri G, Di Girolamo D, Mezzapelle G, Geraci S, Manfrini M, Pavasini R, Barbato E, Campo G. Prognostic Value of QFR Measured Immediately After Successful Stent Implantation: The International Multicenter Prospective HAWKEYE Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):2079-2088. doi: 10.1016/j.jcin.2019.06.003. Epub 2019 Sep 25.

• Responsible Party: Gianluca Campo, Associate Professor, Interventional Cardiologist, University Hospital of Ferrara
• ClinicalTrials.gov Identifier: NCT02811796 History of Changes
• Other Study ID Numbers: 190678
• First Posted: June 23, 2016
• Last Update Posted: January 7, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gianluca Campo, University Hospital of Ferrara:

drug eluting stents; flow fractional reserve; prognosis; angio-based FFR