Clinical trial NCT04683133: The FAST OCT Study
Official title: Association Between 3D Quantitative Angiography Based FFR and Luminal Obstruction as Detected by Optical Coherence Tomography (OCT): the FAST OCT Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott
name: Pie Medical Imaging
First posted: 2020-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study
Primary purpose: DIAGNOSTIC

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI
timeFrame: 0 days
Secondary outcomes:
measure: The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI
timeFrame: 0 days
measure: The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI
timeFrame: 0 days
measure: Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI
timeFrame: 0 days
measure: Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI
timeFrame: 0 days
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
References: