3D-angio-based FFR, Coronary Arteriosclerosis, Myocardial Revascularization, NSTEMI - Non-ST Segment Elevation MI, Tomography, Optical Coherence, Unstable Angina
Conditions
Keywords
OCT, 3D-angio-based FFR, Coronary Arteriosclerosis, NST-ACS
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
Interventions
DIAGNOSTIC_TESTOptical coherence tomography assessment
Optical coherence tomography assessment of coronary arteries with intermediate to severe stenosis
Sponsors
Abbott
Pie Medical Imaging
Erasmus Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI | 0 days | The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 pre-PCI |
| The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI | 0 days | The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI |
| Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI | 0 days | Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI |
| Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI | 0 days | Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI |
Countries
Netherlands
Outcome results
None listed