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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04683133
Other study ID # The FAST OCT study
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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