measurement of FFR: use of pressure-derived FFR to assess the hemodynamic significance of coronary stenoses
measurement of Pd/Pa: use of resting distal coronary pressure to aortic pressure ratio (Pd/Pa) to assess the hemodynamic significance of coronary stenoses
Study summary
This is a prospective, randomized, controlled, multicenter, open-label study designed to assess whether vFFR is non-inferior to FFR in assessment of intermediate coronary stenosis in terms of the occurrence of MACE during 12 months after randomization.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age \>18 years
* Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
* Eligible for coronary angiography and/or PCI
* Coronary artery disease in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed de novo coronary stenosis in which the physiological severity of the lesion is in question (typically 40-80% diameter stenosis).
* Stable angina or acute coronary syndrome (non-culprit vessels only and outside of primary intervention during acute STEMI or NSTE-ACS)
* Participation in another interventional study
Exclusion Criteria:
* Previous CABG with patent grafts to the interrogated vessel
* Tandem stenoses separated by more than 10 mm that require separate pressure guide wire interrogation or PCI (not to be interrogated or treated as a single stenosis)
* Total coronary occlusions
* Hemodynamic instability (Killip class III-IV)
* Heavily calcified or tortuous vessels
* Terminal disease with life expectancy of less than 12 months
* STEMI within 48 hours of procedure
* Severe valvular heart disease
* ACS patients with difficulty in assessing which the culprit lesion is
* Significant contraindication to adenosine administration (e.g. Asthma bronchiale)
* Pregnancy
Primary outcome measure(s)
Major Adverse Cardiac Event (MACE) rate — 1 year composite of cardiac death, non-fatal myocardial infarction or unplanned revascularization
Trial sites (8)
Facility
City
Region
Status
Heart Center Dresden - University Clinic
Dresden
Germany
Recruiting
University Clinic Erlangen
Erlangen
Germany
Recruiting
Universitätsklinikum Essen
Essen
Germany
Recruiting
University Clinic Giessen and Marburg
Giessen
Germany
Recruiting
Herzzentrum Leipzig
Leipzig
Germany
Recruiting
University Clinic Leipzig
Leipzig
Germany
Recruiting
Klinikum der Stadt Ludwigshafen
Ludwigshafen
Germany
Recruiting
Lukaskrankenhaus Neuss
Neuss
Germany
Recruiting
More Helios Health Institute GmbH trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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