The FAST OCT Study

Coronary Arteriosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04683133
• Other study ID #: The FAST OCT study
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Optical coherence tomography assessment
Optical coherence tomography assessment of coronary arteries with intermediate to severe stenosis

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (3)

Lead Sponsor	Collaborator
Erasmus Medical Center	Abbott, Pie Medical Imaging

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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