Correlation between 3D Quantitative Angiography Based FFR and luminal obstruction as detected by Optical Coherence Tomography (OCT): the FAST OCT study

Completed

Conditions: Coronary artery disease. Coronary atherosclerosis
10011082

Registration Number: NL-OMON55347

Lead Sponsor: Trialbureau Cardiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

- 18 years or older
- Presenting with non-ST elevation acute coronary syndrome
- One or more coronary vessels with intermediate to severe coronary stenosis
(30% to 90% by visual estimation or online quantitative coronary analysis
(QCA)).
- Target vessel with a reference vessel diameter (RVD) >=2.5 and <= 5.0 mm as
assessed by QCA or visual estimation.
- The patient is willing to participate in the study.
- Target vessel suitable for optical coherence tomography (OCT) imaging

Exclusion Criteria

- Target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow
<3.
- Target lesion located within 5.0 mm of vessel origin.
- Severe tortuosity
- Chronic total occlusion of the target vessel
- Target lesion is located in or supplied by an arterial or venous bypass graft.
- Impaired renal function (eGFR <30ml/min).
- Pregnant or breastfeeding patients.
- Patient has a known allergy to contrast medium.
- Contraindication for the use of nitrates.
- Life expectancy <12 months

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the association between 3D-angio-based FFR<br /><br>values and OCT detected minimum luminal area pre- and post-PCI. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are: (1) The association between 3D-angio-based<br /><br>FFR values and OCT detected causes of luminal obstruction pre-PCI. (2) The<br /><br>association between 3D-angio-based FFR values and OCT detected causes of<br /><br>luminal obstruction post-PCI. (3) Accuracy of 3D-angio-based FFR to detect<br /><br>intraluminal obstructions pre-PCI. (4) Accuracy of 3D-angio-based FFR to detect<br /><br>intraluminal obstructions post-PCI.</p><br>