No registrations found.
ID
Source
Health condition
FFR, post PCI FFR, IVUS, PCI, atherosclerosis, atherosclerose, dotter, post procedurele FFR
Sponsors and support
Intervention
Outcome measures
Primary outcome
Target vessel failure, defined as composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction, coronary artery bypass graft and clinically driven target vessel revascularization.
Secondary outcome
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 a percutaneous coronary intervention (PCI) proved to be a strong and independent predictor of Major Adverse Cardiac Events (MACE). A number of factors can cause a post PCI pressure drop over a treated segment which can be revealed by intravascular ultrasound (IVUS). It is currently unknown if optimization of impaired post PCI FFR with IVUS might improve patient outcome.
The objective of the FFR-REACT trial is to assess if FFR guided PCI optimization directed by High Definition (HD)-IVUS in patients with a post-PCI FFR below 0.90 will improve target vessel failure. In this prospective trial 290 patients with a post PCI FFR <0.90 will be randomized (1:1) to either standard of care (no additional intervention) or IVUS-directed optimization to a FFR ≥ 0.90 (treatment arm). Assuming that 45% of patients will have a post PCI FFR <0.90, approximately 640 patients undergoing PCI will need to be enrolled. Post PCI FFR measurements will be performed in all patients. The total follow-up period for all patients will be 3 years.
The primary study end point is defined as target vessel failure, a composite of cardiac death, target-vessel myocardial infarction and clinically driven TVR at 1 year.
This study will provide novel insights for a potentially new patient group where post PCI FFR is followed by IVUS to optimize therapy.
Study design
Patients will be followed-up at 6 months, 1, 2 and 3 years post PCI
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.
Joost Daemen
office Ad-342, 's Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 703 56 65/+31 6 205 972 54
Email j.daemen@erasmusmc.nl
Joost Daemen
office Ad-342, 's Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 703 56 65/+31 6 205 972 54
Email j.daemen@erasmusmc.nl
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 successfully treated by PCI and stenting
4. Written informed consent;
5. The patient agrees to the follow
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. Unsuccessful stenting
5. PCI without stenting
6. Inability to perform post procedure FFR
7. 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
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 |
|---|---|
| NTR-new | NL6523 |
| NTR-old | NTR6711 |
| Other | METC-Rotterdam : MEC-2017-489 |