The FAST OCT Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-12-31

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

Conditions

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

Keywords

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OCT 3D-angio-based FFR Coronary Arteriosclerosis NST-ACS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm

Optical coherence tomography evaluation of coronary arteries with intermediate to severe stenosis.

Group Type OTHER

Optical coherence tomography assessment

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Optical coherence tomography assessment

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

Intervention Type DIAGNOSTIC_TEST

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Joost Daemen

Interventional Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erasmus Medical Center

Rotterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Facility Contacts

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Joost Daemen, MD;PhD

Role: primary

Maria Natalia Tovar Forero, MD

Role: backup

Other Identifiers

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