Fractional Flow Reserve, FFR Diabetes Mellitus Optimal Coherence Tomography (OCT) Thin-cap fibroatheroma (TCFA) non-hemodynamic significant coronary stenotic lesion
Conditions
Interventions
DM patients bearing target lesions {Any de novo lesion with an angiographic visual estimation of ≥
40%- ≤
80% Diameter Stenosis (DS) that is located in a non-grafted coronary segment. In patients with an MI at presentation the target lesion should be different from the culprit lesion} and have undergone
65µ) (group B). All patients that had a positive FFR and therefore have been treated with PCI as per standard care in all target lesions will also be followed (group C), however if after the PCI there
Sponsors
Maatschap Cardiology Isala Hospital, Zwolle
Dokter van Heesweg 2
Zwolle
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age ¡Ý 18 years 2. History of DM with any indication for angiography (Stable Angina (SA) or any type of Acute Coronary Syndrome (ACS) including ST-Elevation MI). 3. Coronary angiography, including FFR and OCT imaging of at least one coronary de novo stenosis in a native not-grafted vessel with a visually estimated diameter stenosis (DS) of ¡Ý 40 - ¡Ü 80% (target lesion) . Target lesion should be other than the culprit lesion(s) in patients presenting with MI (STEMI or non-STEMI).
Exclusion criteria
Exclusion criteria: 1. TIMI flow < 3 in the target lesion(s) 2. Target lesion reference diameter (on visual estimation) < 2.0 mm 3. Known left ventricular ejection fraction <30% 4. Known malignancy 5. Life expectancy < 2 years 6. Unwilling or unable to provide inform consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The per patient incidence of the target lesion(s) related composite MACE defined as Cardiac Death, MI, clinically-driven target lesion revascularisation or hospitalization due to unstable or progressive angina at 18 months in the FFR-negative No-TCFA (Group A) and FFR-negative TCFA (Group B). | — |
Secondary
| Measure | Time frame |
|---|---|
| The per patient incidence of the target lesion(s) related composite MACE: Cardicac death, MI, clinically- driven revascularization or hospitalization due to unstable or progressive angina between FFR-negative TCFA (Group B) and the group of patients with PCI-treated FFR-positive lesions (Group C). 2) The per patient incidence composite MACE: Cardiac eath, MI, any clinically driven-revascularization or hospitalization due to unstable or progressive angina between FFR-negative TCFA (Group B) and the group of patients with PCI treated FFR positive lesions (Group C). 3) The incidence of MACE (Cardiac death, MI, any clinically driven-revascularization or hospitalization due to unstable or progressive angina) deriving from non PCI treated lesions between TCFA hosting patients anywhere in the major coronary of stentable size vs. patients with no TCFA (this analysis will be run in the total pool of patients after treatment of all FFR positive lesions and does not take in account the angiographic severity of the lesions ie. the location of the TCFA can be elsewhere than the target lesion ) | — |
Contacts
Public ContactJ. Klijn
Diagram B.V. Zwolle Dokter Stolteweg 96
Outcome results
None listed