The FAST OCT Study

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