NCT02811796

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
602

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
2 countries

7 active sites

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

June 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

2.1 years

First QC Date

June 21, 2016

Last Update Submit

April 28, 2021

Conditions

PrognosisStents

Keywords

drug eluting stentsflow fractional reserveprognosisangio-based FFR

Outcome Measures

Primary Outcomes (1)

  • Device-oriented cardiac events

    cumulative occurrence of cardiac death, target vessel myocardial infarction, target lesion revascularization

    1-year

Secondary Outcomes (6)

  • cardiac death

    1-year

  • all-cause mortality

    1-year

  • any myocardial infarction

    1-year

  • target vessel revascularization

    1-year

  • stent thrombosis

    1-year

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

angio-based FFR estimationOTHER

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.

angio-based FFR estimation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • successfull percutaneous coronary intervention and stent implantation

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location

ASP Agrigento

Agrigento, Italy

Location

Ospedale Civile

Agrigento, Italy

Location

Unknown Facility

Caserta, Italy

Location

San Luigi Gonzaga

Orbassano, Italy

Location

Ospedale Civile

Seriate, Italy

Location

Hospital Clinic

Barcelona, Spain

Location

Related Publications (2)

  • Biscaglia S, Uretsky BF, Tebaldi M, Erriquez A, Brugaletta S, Cerrato E, Quadri G, Spitaleri G, Colaiori I, Di Girolamo D, Scoccia A, Zucchetti O, D'Aniello E, Manfrini M, Pavasini R, Barbato E, Campo G. Angio-Based Fractional Flow Reserve, Functional Pattern of Coronary Artery Disease, and Prediction of Percutaneous Coronary Intervention Result: a Proof-of-Concept Study. Cardiovasc Drugs Ther. 2022 Aug;36(4):645-653. doi: 10.1007/s10557-021-07162-6. Epub 2021 Apr 8.

    PMID: 33830399DERIVED

  • 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.

    PMID: 31563688DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Interventional Cardiologist

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 23, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2018

Study Completion

April 1, 2021

Last Updated

April 29, 2021

Record last verified: 2021-04

Locations

IT(6)ES(1)