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| Name | Class |
|---|---|
| Vilnius University | OTHER |
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A single center, prospective, observational study to compare fractional flow reserve (FFR) and intravascular ultrasound (IVUS) percutaneous coronary intervention (PCI) optimization strategies on the functional PCI result (assessed with FFR) immediately post PCI and at 9-12 months after the treatment of long coronary artery lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVUS PCI optimization group | PCI will be optimized according to the IVUS. IVUS will be performed before PCI and will be used to select PCI strategy. Operators will try to reach an optimal anatomical PCI result as assessed by IVUS aiming for the following criteria:
After stent optimization an IVUS run will be performed. The IVUS run will be considered as final when further anatomical optimization will not be thought to be possible. |
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| Historical FFR PCI optimization group | The goal will be to achieve the optimal functional result, defined as an FFR post PCI ≥ 0.95. Further stented segment post-dilatation will be mandatory if FFR post PCI < 0.95. In case of a clear evidence of significant atheroma proximal or distal to the stented segment, the operators will be encouraged to optimize the functional result further by implanting additional stents. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVUS guided PCI optimization | Procedure | PCI to long lesion will be optimized according to the IVUS. |
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| Measure | Description | Time Frame |
|---|---|---|
| The rate of optimal functional PCI result | Post PCI FFR value < 0.9 | One year |
| The rate of poor functional PCI result | Post PCI FFR value ≤ 0.8 | One year |
| The rate of optimal anatomical PCI result | If all the four following IVUS criteria met: (1) good stent apposition; (2) good stent expansion (minimal stent area (MSA) >90% of distal reference lumen area and/or MSA ≥5.5mm2); (3) plaque burden 5mm proximal and distal to the stent <50%); (4) no stent edge dissection. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of target vessel failure (TVF) | Composite endpoint (target vessel related death (TV-death), target vessel related myocardial infarction (TV-MI), any target vessel revascularization (TV-R)) | One year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with functionally significant long coronary artery lesions amenable to percutaenous coronary intervention.
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| Name | Affiliation | Role |
|---|---|---|
| Giedrius Davidavicius, PhD, prof | Vilnius University Hospital Santaros Klinikos | Study Chair |
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| FFR guided PCI optimization | Procedure | PCI to long lesion will be optimized according to the FFR. |
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| FFR measurement | Diagnostic Test | Fractional flow reserve protocol will be applied for both FFR-guided and IVUS-guided PCI groups. FFR will be measured according to the standard practice using intravenous adenosine. FFR will be recorded before PCI at the distal third of the coronary artery and after PCI at the same location. In FFR optimization group more than one post PCI FFR measurements could be acquired if the operators performed additional optimization. In IVUS optimization group only one post PCI FFR measurement will be recorded after which the procedure will be considered to be finished, and no further interventions will be undertaken. The same FFR measurements will be performed at 9-12 months follow-up. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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