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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
| Pie Medical Imaging | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other | Optical coherence tomography evaluation of coronary arteries with intermediate to severe stenosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical coherence tomography assessment | Diagnostic Test | Optical coherence tomography assessment of coronary arteries with intermediate to severe stenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | Netherlands |
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| ID | Term |
|---|---|
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D000789 | Angina, Unstable |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study
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The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-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 pre-PCI | 0 days |
| 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 |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |