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Non Culprit Functional Evaluation With 3D Angio QFR in STEMI PCI Procedure

A

Azienda Ospedaliera Sant'Anna e San Sebastiano

Status

Unknown

Conditions

Coronary Artery Disease
Percutaneous Coronary Intervention
STEMI - ST Elevation Myocardial Infarction

Treatments

Other: QFR measurement by dedicated workstation on xrays angio selected runs

Study type

Observational

Funder types

Other

Identifiers

NCT02998853
AOStAnnaSS

Details and patient eligibility

About

Reliability of 3D angio QFR functional evaluation of all non culprit lesions >50% in STEMI patients during first acute procedure

Full description

3DAngio QFR is an angiographic based tool for coronary stenosis functional assessment: it is validated versus Adenosine FFR(ADOFFR) by several studies (FAVOR, VIRTU-1) ; in particular post contrast QFR (cQFR) showed a very good correlation with ADOFFR. Furthermore ADOFFR in non culprit vessel in acute stage of STEMI correlates well with ADOFFR of the same non culprit lesion in staged procedure. Aim of the study is to find a valid correlation between cQFR in acute study and ADOFFR in the staged procedure. A positive result may lead to a fast, easy and cost effective acute functional non culprit lesions evaluation during acute procedure for STEMI patients, selecting those,if any, to be treated immediately or in a staged procedure.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • STEMI/NSTEMI pts with at least 1 non culprit lesion > 50%
  • Age > 18 years
  • Able to provide signed informed consent
  • Angiographic inclusion criteria:
  • Indication for FFR in at least one stenosis:
  • Diameter stenosis of 50%-90% by visual estimate
  • Reference vessel size > 2 mm in stenotic segment by visual estimate

Exclusion criteria

  • Severe asthma or severe chronic obstructive pulmonary disease
  • Severe heart failure (NYHA≥III)
  • S-creatinine>150µmol/L or GFR<45 ml/kg/1.73m2
  • Allergy to contrast media or adenosine
  • Atrial fibrillation

Angiographic exclusion criteria:

poor coronary opacification marked overlapping marked tortuosity angio acquisition protocol incomplete

Trial contacts and locations

1

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Central trial contact

Domenico Di Girolamo, MD; Giuseppe Mercone, MD

Data sourced from clinicaltrials.gov

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