The FAST OCT Study

Not Applicable

• Conditions: Tomography, Optical Coherence; NSTEMI - Non-ST Segment Elevation MI; Coronary Arteriosclerosis; Myocardial Revascularization; Unstable Angina; 3D-angio-based FFR
• Interventions: Diagnostic Test: Optical coherence tomography assessment

• Registration Number: NCT04683133
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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

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 Timeline

• Status Verified: 2020-12
• Study Start: 2020-12-01
• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-21
• Last Update Submitted: 2020-12-21
• Study First Posted: 2020-12-24
• Last Update Posted: 2020-12-24
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Optical coherence tomography assessment	Optical coherence tomography evaluation of coronary arteries with intermediate to severe stenosis.

Primary Outcome Measures

Name	Time	Method
The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI	0 days	The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands