The FAST OCT Study

NCT04683133 | Unknown FDA Device

• 1 other identifier: The FAST OCT study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  0 days

• 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

  0 days

Study Arms (1)

Single arm

OTHER

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

Diagnostic Test: Optical coherence tomography assessment

Interventions

Optical coherence tomography assessment DIAGNOSTIC_TEST

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

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Abbott: collaborator
• Pie Medical Imaging: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction; Angina, Unstable; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist

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

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: December 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)