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Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses

ConditionsCoronary Artery DiseaseCoronary Artery Stenoses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelios Health Institute GmbH

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • measurement of FFR

    Diagnostic test

    use of pressure-derived FFR to assess the hemodynamic significance of coronary stenoses

  • measurement of Pd/Pa

    Diagnostic test

    use of resting distal coronary pressure to aortic pressure ratio (Pd/Pa) to assess the hemodynamic significance of coronary stenoses

Treatment groups

1,054 Participants
are divided into 2 treatment groups
Group A: Pd/Pa guided TherapyActive comparator 1 intervention
Group B: FFR guided therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major Adverse Cardiac Event (MACE) rate

composite of cardiac death, non-fatal myocardial infarction or unplanned revascularization

Time frame
1 year

Secondary outcomes

1

MACE during long-term follow-up

Time frame
2 and 5 years
2

Each component of the primary endpoint assessed by structured telephone interview and verification by hospital reports

Time frame
1, 2 and 5 years
3

Repeat revascularization (PCI or CABG) assessed by structured telephone interview and verification by hospital reports in case of event

Time frame
1, 2 and 5 years
4

All-cause mortality

Time frame
1, 2 and 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helios Health Institute GmbH

Lead sponsor

Heart Center Leipzig - University Hospital

Collaborator

Source ClinicalTrials.gov
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