To assess if PCI optimization using High Definition (HD)-IVUS in patients with a post-PCI FFR below 0.90 will improve target vessel failure.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Target vessel failure (TVF), a composite of cardiac death, target-vessel
myocardial infarction and clinically driven TVR at 1 year.
Secondary outcome
Secondary safety endpoint (at 6 months, 1, 2 and 3 years follow-up)
(Definitions Appendix IV)
The individual components of the primary endpoint (cardiac death, target vessel
MI, clinically driven target vessel revascularization)
All-cause death
Target lesion revascularization
Target vessel revascularization
Any coronary revascularization
Non-fatal myocardial infarction
Stent thrombosis (according the ARC criteria)
Peri-procedural MI
Change in post-procedural Pd/Pa and FFR after optimization therapy
Acute kidney injury
Stroke
Periprocedural complications
Correlation outcome of proximal versus stent versus distal FFR drop in
categories of 5% pressure drop.
Correlation of FFR segmental drop and minimum luminal area (MLA ) on IVUS and
3D QCA
Correlation of Pd/Pa and FFR, both dependent and independent of IVUS findings
Correlation of Pd/Pa and FFR and clinical endpoints
Operators PCI strategy change dependent on the information received from either
FFR or IVUS
Background summary
Fractional flow reserve (FFR) after stenting proved to be a strong and
independent predictor of Major Adverse Cardiac Events (MACE) at 1 year. A
number of factors can cause a post Percutaneous Coronary Intervention (PCI)
pressure drop over a treated segment. Substantial evidence exists regarding the
benefit of Intravascular Ultrasound (IVUS)-guided as compared to
angiography-guided PCI. Despite the fact that previous studies demonstrated
that FFR after stenting was <0.90 in approximately 45% of the patients,
post-PCI FFR is not routinely performed and it is currently unknown if
additional interventions to optimize FFR post stenting would improve patient
outcome.
Study objective
To assess if PCI optimization using High Definition (HD)-IVUS in patients with
a post-PCI FFR below 0.90 will improve target vessel failure.
Study design
Prospective randomized controlled trial
Intervention
FFR-guided optimization directed by the ACIST HDi® IVUS System using the
Kodama® IVUS catheter will be performed in the treatment arm. Patients will be
followed for up to 3 years.
Study burden and risks
Post PCI FFR measurement is safe with an additional risk for complications
<0.5%. Previous studies demonstrated that target vessel failure is
significantly higher in patients with a post PCI FFR <0.9 as compared to those
with a post PCI FFR >=0.90 (3 to 4 fold). IVUS guided PCI optimization after
stenting proved to be safe with a low rate of additional complications.
Patients in the treatment arm will undergo IVUS assessment of the stented
segment with the attempt to visualize the cause of low post-procedural FFR and
drive further intervention to correct the final FFR to > 0.90 (e.g. residual
disease proximal or distal to the stented segment, stent underexpansion or
dissections). Patients in the control arm will receive standard of care
excluding additional imaging upon PCI completion according to routine clinical
practice. Follow-up burden will be low and will consist of telephone interviews
at 6, 24 and 36 months and a clinical follow-up including electrocardiogram
(ECG) at 12 months (the latter being routine clinical care).
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
1. Age >=18
2. Stable- or unstable angina or Non-ST segment elevation myocardial infarction
3. Target lesion stenosis >= 50% by visual estimation or QCA
Exclusion criteria
1. Patients with ST-elevation myocardial infarction (STEMI) or evidence of
myocardial infarction within 72 hours before the index procedure
2. Target vessel distal reference diameter <2.25mm
3. Cardiogenic shock or severe hemodynamic instability
4. Inability to perform post procedure FFR
5. The patient has other medical illnesses (i.e., cancer) that may cause the
patient to be non-compliant with the protocol, confound the data interpretation
or is associated with limited life expectancy (i.e., less than one year).
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 |
|---|---|
| CCMO | NL62550.078.17 |