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Prospective Comparison of Angiography-Derived and Wire-Based Physiological Assessment Using vFFR, QFR, iFR, and RFR

Prospective Comparison of Angiography-Derived and Wire-Based Physiological Assessment Using vFFR, QFR, iFR, and RFR - vFFR_QFR vs. iFR/RFR

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038182
Enrollment
100
Registered
2025-11-12
Start date
2019-09-17
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease (CHD) I25.1

Interventions

Group 1: Inclusion required at least one intermediate non-culprit lesion (40-90% diameter stenosis) in a coronary artery with a reference diameter = 2.5 mm. vFFR and QFR were calculated in triplicate

Sponsors

Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Eligibility criteria included patients aged 18 years or older presenting with chronic coronary syndrome (CCS) or requiring staged assessment of non-culprit lesions following non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI), as depicted in Figure 1. Inclusion required at least one intermediate non-culprit lesion (40-90% diameter stenosis) in a coronary artery with a reference diameter = 2.5 mm

Exclusion criteria

Exclusion criteria: Exclusion criteria included STEMI within 72 hours, cardiogenic shock, severe renal impairment (GFR = 30 mL/min/1.73 m²), left ventricular ejection fraction < 30%, ventricular arrhythmias, contrast agent- or adenosine intolerance, severe vessel tortuosity, lesion overlap, or inadequate image quality. Image quality criteria: 1. Bad contrast filling (n=2) 2. Vessel overlap (n=2) 3. Vessel foreshortening (n=5) 4. Missing projections 15fps (n=2) 5. Table movement (n=1) 6. Significant aortic stenosis (n=1) 7. Side branch analysis (n=2)

Design outcomes

Primary

MeasureTime frame
This study therefore aimed to assess the diagnostic accuracy of vFFR and QFR against iFR and RFR.

Secondary

MeasureTime frame
Inter- and intra-observer reliability of vFFR and QFR.

Countries

Germany

Contacts

Public ContactKarsten Lenk

Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig

karsten.lenk@medizin.uni-leipzig.de+493419720956

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026