To determine the safety and effectiveness of a vFFR guided strategy versus an invasive FFR guided strategy for coronary revascularization.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Composite of all-cause death, any myocardial infarction, or any
revascularization at 1 year.
Secondary outcome
1. Patient-oriented Composite Endpoint (POCE) defined as all-cause death, any
stroke, any myocardial infarction, and any revascularization
2. Device-oriented Composite Endpoint (DOCE) defined as the composite of
cardiovascular death, target-vessel MI, clinically indicated repeat
revascularization of the target lesion
3. Study-oriented Composite Endpoint (SOCE) defined as the composite of
cardiovascular death, study-vessel or target vessel MI, or study-vessel or
target vessel revascularization
4. Target-vessel failure defined as a composite of cardiac death, target vessel
myocardial infarction, or clinically indicated target-vessel revascularization
5. Target-lesion Failure defined as a composite of cardiac death, target vessel
myocardial infarction, or clinically indicated target-lesion revascularization
6. Study-vessel failure defined as a composite of cardiac death, study vessel
myocardial infarction, or clinically indicated study-vessel revascularization
7. Definite and probable stent thrombosis
Background summary
Invasive coronary angiography has served as the cornerstone for the diagnosis
of patients with known or suspected coronary artery disease (CAD).
Unfortunately, the technique is limited in its ability to assess the
hemodynamic impact of intermediate coronary artery stenosis resulting in under-
or overestimation of disease severity. In order to overcome this limitation,
Fractional Flow Reserve (FFR) has emerged as the gold standard to assess the
hemodynamic importance of intermediate coronary artery lesions and to guide
revascularization.
FFR assessment requires the use of a dedicated guidewire or microcatheter along
with the administration of a hyperemic agent associated with temporary patient
discomfort. Recently a new method was validated which calculates FFR based on
blood pressure and a 3D reconstruction of the routinely obtained coronary
angiogram (vFFR).
Study objective
To determine the safety and effectiveness of a vFFR guided strategy versus an
invasive FFR guided strategy for coronary revascularization.
Study design
The FAST III is a randomized controlled, open-label, multicenter,
international, non-inferiority, strategy trial. A total of 2228 participants
will be randomized in a 1:1 fashion to either vFFR or FFR guided
revascularization. Patients will be consented prior to the procedure and then
followed up to 12 (+1) months after randomization. The primary endpoint is
analyzed at 12 months after randomization.
Intervention
(v)FFR guided revascularization
Study burden and risks
Participating in the study does not impose additional risks to those compared
to patients undergoing standard coronary angiography, percutaneous coronary
intervention and coronary artery bypass grafting.
There are no risks associated with the use of 3D-angio-based FFR analysis since
it is performed from routinely obtained angiographic data.
Benefits from participating in this study are no different from when standard
of care is followed. However, potential benefits of randomization to the vFFR
arm might include the benefit of avoiding vessel manipulation. Possible
benefits may be found for future patients treated with vFFR guided PCI based
upon results of the study.
Westblaak 98
Rotterdam 3012KM
NL
Westblaak 98
Rotterdam 3012KM
NL
Listed location countries
Age
Inclusion criteria
2. Presenting with silent ischemia, stable angina, non-ST-elevation acute
coronary syndrome (NSTE-ACS), or stabilized STEMI (>72h post culprit treatment)
3. Coronary artery disease with at least one native artery in which the
stenosis severity is questionable (typically 30-80% stenosis)
4. vFFR guided revascularization considered feasible (see vFFR training manual)
Exclusion criteria
1. Acute treatment of ST-elevation myocardial infarction (STEMI)
2. Cardiogenic shock or severe hemodynamic instability at the time of
intervention (as defined by the interventionalist) or use of left ventricular
assist device
3. A study lesion cannot be in a vessel with a distal Thrombolysis In
Myocardial Infarction (TIMI) flow <3.
4. A study lesion cannot have evidence of thrombus.
5. Known untreated severe valvular heart disease
6. A study lesion cannot be located in or supplied by an arterial or venous
bypass graft
7. History of cardiac allograft transplantation
8. A study lesion cannot be aorto-ostial with an estimated diameter stenosis
>50%
9. Severe tortuosity precluding the acquisitions of 2 orthogonal projections of
the target vessel with minimal overlap or foreshortening
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | ClinicalTrials.gov: NCT04931771 |
| CCMO | NL77863.078.21 |