FFR, post PCI FFR, IVUS, PCI, atherosclerosis, atherosclerose, dotter, post procedurele FFR
Conditions
Interventions
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.
Sponsors
Erasmus Medical Center
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactJoost Daemen
P.O. Box 2040, 3000 CA Rotterdam, The Netherlands, internal postal address Ba-593
Outcome results
None listed