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Investigator-initiated, international, multicentre, observational study with two cohorts.
The two study cohorts will be:
Cohort A: to understand if the local blood flow patterns (associated with low WSS), as evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive images, may better predict the clinical outcome of patients with bifurcated coronary lesions treated by PCI.
Cohort B: to understand if the local blood flow patterns (associated with low WSS), as evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive images, may better predict the clinical outcome of patients with sub-critical bifurcated lesions managed conservatively.
Coronary angiography and OCT images will be combined to obtain a three-dimensional model of the diseased coronary vessels that will be used to calculate the local blood flow patterns and the time-averaged WSS at the bifurcated lesion level by using computational fluid dynamics software.
Baseline (in patients both managed conservatively and treated by PCI) and post-PCI (in patients treated by PCI) images will be processed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Patients with bifurcated coronary lesions treated by percutaneous coronary interventions. |
| |
| Cohort B | Patients with untreated bifurcated coronary lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary angiography and optical coherence tomography | Procedure | Coronary angiography and OCT images will be combined to obtain a three-dimensional model of the diseased coronary vessels that will be used to calculate the local blood flow patterns and the arterial time-averaged wall shear stress at the bifurcated lesion level |
| Measure | Description | Time Frame |
|---|---|---|
| Target bifurcation failure (TBF) | - Target bifurcated lesion-related major adverse coronary event (MACE) defined as the composite of:
| 1,6,12,18,24 and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Target vessel failure | - In the absence of target bifurcated lesion-related MACE, target bifurcated lesion angiographic failure defined, in patients treated by PCI, as: > 50% restenosis on the main vessel (MV) or TIMI (Thrombolysis In Myocardial Infarction) flow < 3 on the side branch (SB) at angiography eventually performed during the clinical course. | 1,6,12,18,24 and 36 months |
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Inclusion Criteria
Exclusion Criteria
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Patients with stable or unstable coronary artery disease due to atherosclerosis involving a major bifurcation site, who undergo diagnostic or interventional invasive percutaneous coronary procedures with the use of optical coherence tomography (OCT) based on operator's choice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Burzotta, MD | Contact | +39 3494295290 | francesco.burzotta@unicatt.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Burzotta, MD | Policlinico A. Gemelli. Università Cattolica del Sacro Cuore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico A. Gemelli. Università Cattolica del Sacro Cuore | Roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Bifurcated lesion angiographic failure |
| 1,6,12,18,24 and 36 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |