The FAST OCT Study

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Arteriosclerosis; Unstable Angina; NSTEMI - Non-ST Segment Elevation MI; Tomography, Optical Coherence; Myocardial Revascularization; 3D-angio-based FFR
• Intervention / Treatment: Diagnostic test: Optical coherence tomography assessment

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus Medical Center
    • Contact: Joost Daemen, MD;PhD; Phone Number: +31 10 703 5260; Email: j.daemen@erasmusmc.nl
    • Contact: Maria Natalia Tovar Forero, MD; Phone Number: +31 10 703 8896; Email: m.tovarforero@erasmusmc.nl
    • Principal Investigator: Joost Daemen, MD;PhD
    • Sub-Investigator: Maria Natalia Tovar Forero, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm; Optical coherence tomography evaluation of coronary arteries with intermediate to severe stenosis.	Diagnostic test: Optical coherence tomography assessment; Optical coherence tomography assessment of coronary arteries with intermediate to severe stenosis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Abbott; Pie Medical Imaging

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: OCT; Coronary Arteriosclerosis; 3D-angio-based FFR; NST-ACS
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Angina Pectoris; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Angina, Unstable
• Other Study ID Numbers: The FAST OCT study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes