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Clinical Trials in Germany / NCT03497637
Recruiting Not applicable

Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses

NCT03497637 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2020-10-23
Last updated
2024-11-25

Condition(s) studied

Coronary Artery DiseaseCoronary Artery Stenoses

Investigational drug(s) / intervention(s)

measurement of FFRmeasurement of Pd/Pa

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)

Trial sites (8)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT03497637 on ClinicalTrials.gov ↗ ← All trials in Germany