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Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses

RecruitingNAAges 18 Years - anyAllHelios Health Institute GmbH
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • measurement of FFR
  • measurement of Pd/Pa
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Where

8 sites
Heart Center Dresden - University Clinic
Dresden, Germany
University Clinic Erlangen
Erlangen, Germany
Universitätsklinikum Essen
Essen, Germany
University Clinic Giessen and Marburg
Giessen, Germany
Herzzentrum Leipzig
Leipzig, Germany
University Clinic Leipzig
Leipzig, Germany
Klinikum der Stadt Ludwigshafen
Ludwigshafen, Germany
Lukaskrankenhaus Neuss
Neuss, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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