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Veiligheid en effectiviteit van PCI optimalisatie door het gebruik van hoge resolutie IVUS vergeleken met de standaard behandeling bij patiŽnten met een lage FFR na de procedure

- candidate number27936
- NTR NumberNTR6711
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-sep-2017
- Secondary IDsMEC-2017-489 METC-Rotterdam
- Public TitleVeiligheid en effectiviteit van PCI optimalisatie door het gebruik van hoge resolutie IVUS vergeleken met de standaard behandeling bij patiŽnten met een lage FFR na de procedure
- Scientific TitleFFR guided PCI optimization directed by high-definition IVUS versus standard of care: the randomized FFR-REACT trial
- hypothesis
- Healt Condition(s) or Problem(s) studiedAtherosclerose, Percutaneous Coronary Intervention (PCI), Fractional Flow Reserve (FFR) , IntraVascular UltraSound (IVUS)
- Inclusion criteria1. 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 criteria1. 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).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2017
- planned closingdate1-okt-2022
- Target number of participants640
- InterventionsFFR-guided optimization directed by the ACIST HDiģ IVUS System using the Kodamaģ IVUS catheter will be performed in the treatment arm. Patients will be followed for up to 3 years.
- Primary outcomeTarget 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 outcomeThe 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
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
- TimepointsPatients will be followed-up at 6 months, 1, 2 and 3 years post PCI
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
ACIST Medical Systems, Inc. Corporate Headquarters
- Publications
- Brief summaryFractional 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.
- Main changes (audit trail)
- RECORD19-sep-2017 - 29-dec-2017

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