Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
NCT ID: NCT03497637
Last Updated: 2024-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1054 participants
INTERVENTIONAL
2020-10-23
2026-11-01
Brief Summary
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Detailed Description
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Vessel-FFR (vFFR) is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on computation of two angiographic projections. The vFFR values at each point along the vessel are color-coded and superimposed on the 3D epicardial model and cut-off values of ≤0.80 identical to standard invasive FFR apply.
These developments may translate towards more physiology guided intervention bearing the potential to improve clinical outcomes in patients with stable CAD. The ability to derive FFR values from routinely performed coronary angiograms, without the practical drawbacks that limit invasive techniques, could have an important impact on daily clinical practice.
To date no randomized outcome-based clinical trial has compared an image-based FFR methodology with standard invasive FFR in terms of subsequent clinical outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pd/Pa guided Therapy
use of resting distal coronary pressure to aortic pressure ratio (Pd/Pa) 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
FFR guided therapy
use of pressure-derived FFR to assess the hemodynamic significance of coronary stenoses
measurement of FFR
use of pressure-derived FFR to assess the hemodynamic significance of coronary stenoses
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Heart Center Leipzig - University Hospital
OTHER
Helios Health Institute GmbH
OTHER
Responsible Party
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Principal Investigators
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Holger Thiele, MD
Role: PRINCIPAL_INVESTIGATOR
Heart Center Leipzig - University Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Felix Woitek, Dr.
Role: primary
Luise Gaede, Dr.
Role: primary
Tienush Rassaf, Prof. Dr.
Role: primary
Holger Nef, Prof.
Role: primary
Holger Thiele, MD
Role: primary
Ulrich Laufs, Prof.
Role: primary
Uwe Zeymer, Prof.
Role: primary
Michael Haude, Prof.
Role: primary
Other Identifiers
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HRC045277
Identifier Type: -
Identifier Source: org_study_id
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