The FAST OCT Study

Erasmus Medical Center200 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

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

Interventions

Optical coherence tomography assessmentDIAGNOSTIC_TEST

Optical coherence tomography assessment of coronary arteries with intermediate to severe stenosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

Outcomes

Primary Outcomes

The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI

Time frame: 0 days

Secondary Outcomes

The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI

Time frame: 0 days

The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI

Time frame: 0 days

Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI

Time frame: 0 days

Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI

Time frame: 0 days

Data from ClinicalTrials.gov

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