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The FAST OCT Study

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Erasmus University

Status

Unknown

Conditions

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

Treatments

Diagnostic Test: Optical coherence tomography assessment

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04683133
The FAST OCT study

Details and patient eligibility

About

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.

Full 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

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

Single arm
Other group
Description:
Optical coherence tomography evaluation of coronary arteries with intermediate to severe stenosis.
Treatment:
Diagnostic Test: Optical coherence tomography assessment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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