Clinical trial NCT03497637: Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Official title: Comparison of Non-Invasive Vessel Fractional Flow Reserve Calculated From Angiographic Images Versus Fractional Flow Reserve in Patients With Intermediate Coronary Artery Stenoses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Stenoses
Lead sponsor: Helios Health Institute GmbH
Sponsor class: OTHER
Collaborators: name: Heart Center Leipzig - University Hospital
First posted: 2018-04-13
Enrollment: 1054
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Coronary angiography is insensitive to assess the physiologic significance of a coronary stenosis. Therefore, clinical guidelines support the use of pressure-derived fractional flow reserve (FFR) to assess the hemodynamic significance of coronary stenosis. Nevertheless, the penetration of FFR in clinical routine continues to be limited by its requirement for pharmacological vasodilation, prolonged procedure time and adverse systemic effects from adenosine.

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.

Eligibility criteria: 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 outcomes:
measure: Major Adverse Cardiac Event (MACE) rate
timeFrame: 1 year
Secondary outcomes:
measure: MACE during long-term follow-up
timeFrame: 2 and 5 years
measure: Each component of the primary endpoint assessed by structured telephone interview and verification by hospital reports
timeFrame: 1, 2 and 5 years
measure: Repeat revascularization (PCI or CABG) assessed by structured telephone interview and verification by hospital reports in case of event
timeFrame: 1, 2 and 5 years
measure: All-cause mortality
timeFrame: 1, 2 and 5 years
measure: Cross-over rate from the one strategy to the other
timeFrame: at intervention
measure: Number of analyzable lesions in both treatment arms
timeFrame: at intervention
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Heart Center Dresden - University Clinic
city: Erlangen
country: Germany
facility: University Clinic Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Gießen
country: Germany
facility: University Clinic Giessen and Marburg
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Leipzig
country: Germany
facility: University Clinic Leipzig
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen
city: Neuss
country: Germany
facility: Lukaskrankenhaus Neuss
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Holger Thiele, MD
role: PRINCIPAL_INVESTIGATOR
References: