The FAST OCT Study

Study Overview
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Brief Summary
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This trial is designed to associate angiography-based fractional flow reserve (3D-angio-based FFR) values with optical coherence tomography findings in pre- and post-percutaneous coronary intervention in patients with non-ST segment elevation acute coronary syndromes.

Detailed Description
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Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study, enrolling up to 200 patients with intermediate to severe coronary stenosis (30-90% diameter stenosis) in patients presenting with NST-ACS requiring coronary angiography assessment. Patients will receive ad-hoc OCT evaluation of the target vessels and offline 3D-angio-based FFR evaluation. The primary study parameter is the association between 3D-angio-based FFR values and OCT detected minimum luminal area pre- and post-PCI

Official Title
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Association Between 3D Quantitative Angiography Based FFR and Luminal Obstruction as Detected by Optical Coherence Tomography (OCT): the FAST OCT Study

Conditions
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Tomography, Optical Coherence, Myocardial Revascularization, NSTEMI - Non-ST Segment Elevation MI, Unstable Angina, Coronary Arteriosclerosis, 3D-angio-based FFR

Intervention / Treatment
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* Diagnostic Test: Optical coherence tomography assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Presenting with NST-ACS At least one coronary vessel with intermediate to severe coronary stenosis (30% to 90% by visual estimation or online 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br>Optical coherence tomography evaluation of coronary arteries with intermediate to severe stenosis. | Diagnostic Test: Optical coherence tomography assessment<br>* Optical coherence tomography assessment of coronary arteries with intermediate to severe stenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI | The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI | 0 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI | The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI | 0 days | 
| The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI | The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI | 0 days | 
| Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI | Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI | 0 days | 
| Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI | Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI | 0 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCT, 3D-angio-based FFR, Coronary Arteriosclerosis, NST-ACS