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Correlation between 3D Quantitative Angiography Based FFR and luminal obstruction as detected by Optical Coherence Tomography (OCT): the FAST OCT study

Correlation between 3D Quantitative Angiography Based FFR and luminal obstruction as detected by Optical Coherence Tomography (OCT): the FAST OCT study - FAST OCT study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55347
Enrollment
140
Registered
2020-11-18
Start date
2020-12-14
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease. Coronary atherosclerosis

Interventions

Coronary angiography and OCT assessment of all epicardial vessels (>=2,5 mm) with intermediate to severe stenosis before and after PCI (if performed). The use of intracoronary physiology (either FFR

Sponsors

Trialbureau Cardiologie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 18 years or older - Presenting with non-ST elevation acute coronary syndrome - One or more coronary vessels with intermediate to severe coronary stenosis (30% to 90% by visual estimation or online quantitative coronary analysis (QCA)). - Target vessel with a reference vessel diameter (RVD) >=2.5 and

Exclusion criteria

Exclusion criteria: - Target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow

Design outcomes

Primary

MeasureTime frame
The primary study parameter is the association between 3D-angio-based FFR values and OCT detected minimum luminal area pre- and post-PCI.

Secondary

MeasureTime frame
The secondary study parameters are: (1) The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI. (2) The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI. (3) Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI. (4) Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)