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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXXESS stent1 | Experimental | AXXESS stent (OCT-guided) |
|
| Conventional DES1 | Experimental | Conventional DES (Biomatrix flex stent, OCT-guided) |
|
| AXXESS stent2 | Active Comparator | AXXESS stent (Angio-guided) |
|
| Conventional DES2 | Active Comparator | Conventional DES (Biomatrix flex stent, Angio-guided) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT-guided PCI with AXXESS stent | Device | The AXXESS stent (Biosensors Europe SA, Morges, Switzerland) is a dedicated self-expanding bifurcation stent eluting the sirolimus analog Biolimus A9 emulsed in a biodegradable polymer. It has the advantage to preserve the ostium of both distal branches and allows additional stent implantation in the distal branches for complete lesion coverage, while reducing large stent overlap and eliminating deformation. Optical coherence tomography (OCT), has enabled the evaluation of strut coverage and arterial healing after DES implantation with a superior resolution and delineation over other imaging modalities. With using these superiorities of OCT, there have been many studies assessing the neointimal coverage following various types of DES implantation in various periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Late loss of side branch(SB) | Late loss was defined as the difference between the minimal luminal diameter (MLD) immediately after the procedure and the MLD at 9-month follow-up, Measured the change in MLD by Quantitative coronary angiography (QCA) | 9 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular (CV) death | death for CV cause (MI, stroke) | 9 months after procedure |
| Myocardial infarction (MI) | MI definition: rise of cardiac biomarker with at least one of the following: Symptoms of ischemia, New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB), Development of pathological Q waves in the ECG, Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality, identification of an intracoronary thrombus by angiography or autopsy |
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Exclusion Criteria:
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|
| OCT-guided PCI with conventional DES (Biomatrix flex stent) | Device | BioMatrix Flex is abluminal biodegradable polymer DES. Its abluminal coating is absorbed after 6 to 9months and turns the DES into a BMS. It combines the proven safety of a DES with an abluminal biodegradable polymer, the prove efficacy of BA9 and an advanced stent design. Optical coherence tomography (OCT), has enabled the evaluation of strut coverage and arterial healing after DES implantation with a superior resolution and delineation over other imaging modalities. With using these superiorities of OCT, there have been many studies assessing the neointimal coverage following various types of DES implantation in various periods. |
|
| Angio-guided PCI with AXXESS stent | Device | The AXXESS stent (Biosensors Europe SA, Morges, Switzerland) is a dedicated self-expanding bifurcation stent eluting the sirolimus analog Biolimus A9 emulsed in a biodegradable polymer. It has the advantage to preserve the ostium of both distal branches and allows additional stent implantation in the distal branches for complete lesion coverage, while reducing large stent overlap and eliminating deformation. We use the conventional coronary angiography. |
|
| Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent) | Device | BioMatrix Flex is abluminal biodegradable polymer DES. Its abluminal coating is absorbed after 6 to 9months and turns the DES into a BMS. It combines the proven safety of a DES with an abluminal biodegradable polymer, the prove efficacy of BA9 and an advanced stent design. We use the conventional coronary angiography. |
|
| 9 months after procedure |
| stent thrombosis (ST) | ST definition: Academic Research Consortium (ARC) definition | 9 months after procedure |
| SB closure | SB closure: TIMI flow < 3 and/or stenosis >75% | 9 months after procedure |
| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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