The primary objective of the study is to assess the safety and efficacy of a pressure microcatheter guided treatment decision and PCI optimization compared to a pressure wire based strategy.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rate of major adverse cardiovascular events (MACE) defined as the combined rate
of all-cause death, myocardial infarction (MI), and unplanned revascularization
between pressure microcatheter and pressure wire strategies at 12-month
follow-up.
Secondary outcome
1. Resource utilization i.e., number of pressure catheters/wires and procedural
time needed to complete the procedure.
2. Procedure time in a pressure microcatheter and pressure-wire guided
strategies: the time from first to the last angiography.
3. In patients undergoing PCI, resource utilization (number of catheters/wires)
between a pressure PIOS-MC and PIOS-PW strategies in patients undergoing PCI.
4. In patients undergoing PCI, the procedural time between a pressure PIOS-MC
and PIOS-PW strategies.
5. In patients undergoing PCI, the rate of target vessel failure (TVF) defined
as the composite of cardiac death, target vessel MI and ischemia-driven target
vessel revascularization (ID-TVR) between PIOS and SOC.
6. Post-PCI FFR between the pressure microcatheter and pressure-wire guided
strategies in patients undergoing PCI.
7. Post-PCI FFR between pressure PIOS and SOC strategies in patients undergoing
PCI.
8. Post-PCI FFR in pressure PIOS-MC and PIOS-PW strategies in patients
undergoing PCI.
9. The proportion of FFR > 0.90 between pressure microcatheter (MC) PIOS and
SOC strategies in patients undergoing PCI.
10. The proportion of FFR > 0.80 in pressure PIOS and SOC strategies in
patients undergoing PCI.
11. The proportion of FFR > 0.80 in pressure PIOS-MC and PIOS-PW strategies in
patients undergoing PCI.
12. The proportion of FFR > 0.90 in pressure PIOS-MC and PIOS-PW strategies in
patients undergoing PCI.
13. Rate of symptoms-free status assessed by the SAQ-7 between a pressure
microcatheter and pressure-wire guided strategies at 12 months follow-up.
14. Rate of all-cause death in a pressure microcatheter and pressure-wire
guided strategies.
15. Rate of myocardial infarction in a pressure microcatheter and pressure-wire
guided strategies.
16. Rate of and unplanned revascularization in a pressure microcatheter and
pressure-wire guided strategies.
17. In patients undergoing PCI, the rate of cardiac death between PIOS and SOC.
18. In patients undergoing PCI, the rate of target vessel MI between PIOS and
SOC.
19. In patients undergoing PCI, the rate of ID-TVR between PIOS and SOC.
20. Rate of PCI-related MI (type 4a) between a pressure PIOS and SOC.
21. Rate of angiographic complications related to vessel wiring (i.e.,
Angiographic dissection >= NHLBI type B, perforations (Ellis classification),
intra-procedural thrombotic events (including slow-flow, no-reflow, side branch
closure, distal embolization, and intra-procedural stent thrombosis, as per the
standard angiographic core laboratory definitions) in a pressure microcatheter
and pressure-wire guided strategies.
22. Predictive capacity of the PPG derived from pressure microcatheter and
pressure wire for post-PCI FFR.
23. Predictive capacity of the PPG derived from pressure microcatheter and
pressure wire for TVF.
24. Predictive capacity of the PPG derived from pressure microcatheter and
pressure wire for target-vessel MI.
25. Predictive capacity of the PPG derived from pressure microcatheter and
pressure wire for ID-TVR.
26. Predictive capacity of the post-PCI residual pressure gradients from
pressure microcatheter and pressure wire for target-vessel target vessel MI.
27. Predictive capacity of the post-PCI residual pressure gradients from
pressure microcatheter and pressure wire for target vessel revascularization.
28. Rate of peri-procedural myocardial infarction stratified by PPG derived
from pressure microcatheter and pressure wire.
29. Rate of peri-procedural myocardial injury stratified by PPG derived from
pressure microcatheter and pressure wire.
30. Rate of Device Deficiencies and Adverse Events related to pressure
microcatheter and pressure wire.
Background summary
Invasive functional evaluation of coronary stenosis to decide upon
revascularization has demonstrated clinical benefit in various clinical
settings and in patients with different risk profiles. Today, guidelines
recommend using resting or hyperemic pressure ratios to assess the hemodynamic
significance of intermediate coronary lesions. Despite the evidence, physiology
guided revascularization is applied only in a small proportion of patients
undergoing PCI. There are several reasons, including the use of pressure wires
of limited performance, which is particularly important when adopted in complex
anatomic scenarios.
In addition to a distal FFR or non-hyperemic resting index value (NHPR), a
pullback manoeuvre can be used to assess the distribution of epicardial
resistance and characterize the pattern of coronary artery disease (CAD) as
either focal or diffuse before PCI. After PCI, a pullback manoeuvre can help
identify residual pressure gradients either inside or outside the stent that
can be addressed by further post-dilatation of another PCI. Pullback manoeuvres
help optimize PCI and achieve a higher degree of functional revascularization,
which has been associated with improved clinical outcomes. However, with
standard pressure wires, pullback manoeuvres lead to loss of wire position,
further discouraging systematic adoption.
Recently, a new device for measuring physiological lesion severity, the
pressure microcatheter, was introduced. The pressure microcatheter provides
similar information to the conventional measurement technique but differs as it
is easily advanced on a customary coronary wire and simplifies pullback
maneuvers. The pressure microcatheter has been shown to provide comparable FFR
results to pressure wires.
To date, there is a vast experience with the pressure microcatheter. Yet, the
widespread applicability of pressure microcatheter in clinical practice will
require studies investigating the equivalence of pressure wire-guided clinical
decision making in terms of patient outcomes when used as a clinical decision
making and optimization tool in patients considered or undergoing PCI.
To date, there is a vast experience with the pressure microcatheter. Yet, the
widespread applicability of pressure microcatheter in clinical practice will
require studies investigating the equivalence of pressure wire-guided clinical
decision making in terms of patient outcomes when used as a clinical decision
making and optimization tool in patients considered or undergoing PCI.
Study objective
The primary objective of the study is to assess the safety and efficacy of a
pressure microcatheter guided treatment decision and PCI optimization compared
to a pressure wire based strategy.
Study design
The INSIGHTFUL-FFR study is an investigator-initiated, international, and
multicenter trial of patients with stable coronary artery disease or stabilized
non-ST elevation acute coronary syndrome (ACS) with epicardial stenosis
considered for PCI aiming at comparing clinical outcomes between pressure
microcatheter and pressure wire-guided strategies.
Following the identification of coronary stenosis, defined as at least one
epicardial lesion between 30% to 90% diameter stenosis (%DS), patients will be
randomized to either pressure microcatheter or pressure wire-based strategies
for clinical decision making. Clinical decision making for PCI could be based
either on FFR or NHPR. FFR or NHPR will support clinical decisions to defer or
treat at the operator discretion. In cases with a positive FFR (<= 0.80) or NHPR
(<=0.89), patients will undergo a hyperemic FFR pullback to guide the PCI
procedure further. PCI will be performed using last-generation drug-eluting
stents (DES) at operator*s discretion. After completing an angiographically
successful PCI, patients will be randomized to FFR-guided stent optimization
(PIOS) or standard of care (SOC).
The sites using an online platform will perform simple randomization (1:1:1:1
ratio) to either pressure microcatheter SOC, pressure wire SOC, pressure
microcatheter PIOS or pressure wire PIOS. PCI treatment will be considered by
the randomized methodology strategy, using the NHPR<=0.89 threshold, and FFR
<=0.80. Subsequently, patients undergoing PCI will follow the pullback-based PCI
optimization (PIOS) or SOC with either the pressure microcatheter or pressure
wire. Patients randomized to any of the four groups in whom NHPR is >0.89 or
FFR >0.80 PCI will be deferred and analyzed as such. The one-step randomization
process in four groups permits an uninterrupted invasive procedure avoiding the
logistic issues related to a second randomization during the invasive procedure
while preserving the statistical power and balance between groups.
Study burden and risks
The potential risks for the patient are the known and common risks during the
diagnostic work-up process or during invasive coronary angiography and PCI but
are unrelated to this study. No additional risks for the patients participating
in this study are expected. This study does not interfere with any common or
generally used test or processes.
The patients will not get a direct benefit by participating in this study. The
results of this study could hopefully give benefit for future patients.
Industriezone Zuid 3, Industrielaan - kantoor 2 4
Erembodegem 9320
BE
Industriezone Zuid 3, Industrielaan - kantoor 2 4
Erembodegem 9320
BE
Listed location countries
Age
Inclusion criteria
1. The subject must be at least 18 years of age and younger than 85 years old.
2. Eligible for elective PCI.
3. Stable angina or ACS (non-culprit vessels only and outside of primary
intervention during acute STEMI)
4. Subject willing to participate and able to understand, read and sign the
Informed Consent.
Exclusion criteria
1. STEMI as clinical presentation.
2. Significant contraindication to adenosine administration (e.g. heart block,
severe asthma)
3. Uncontrolled or recurrent ventricular tachycardia.
4. Hemodynamic instability.
5. Severe valvular disease.
6. Severe renal dysfunction, defined as an eGFR <=30 mL/min/1.73 m2.
7. Comorbidity with life expectancy <= 2 years.
8. Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12
months in the patient presenting with an ACS, or at least 6 months in the
patient presenting with stable CAD, unless the patient is also taking chronic
oral anticoagulation in which case a shorter duration of DAPT may be prescribed
per local standard of care.
9. Planned major cardiac or non-cardiac surgery within 24 months after the
index procedure.
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 |
|---|---|
| ClinicalTrials.gov | NCT05437900 |
| CCMO | NL82417.091.22 |