Coronary Bifurcation Lesions
Conditions
Brief summary
1. To compare the safety and efficacy of AXXESS stent with conventional DES in patients with coronary artery bifurcation disease 2. To assess the impact of optical coherence tomography (OCT) guidance on clinical outcomes following the stent type
Interventions
DEVICEOCT-guided PCI with AXXESS stent
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.
DEVICEOCT-guided PCI with conventional DES (Biomatrix flex stent)
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.
DEVICEAngio-guided PCI with AXXESS stent
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.
DEVICEAngio-guided PCI with PCI with conventional DES (Biomatrix flex stent)
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent prior to any study specific procedures, * Patients ≥ 19 years old, * Patients who are expected to undergo PCI for bifurcation lesions.
Exclusion criteria
* Age\> 85 years, * Cardiogenic shock or unstable patients, * Increased risk of bleeding, anemia, thrombocytopenia, * A need for oral anticoagulation therapy, * Pregnant women or women with potential childbearing, * Life expectancy \< 1 year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late loss of side branch(SB) | 9 months after procedure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular (CV) death | 9 months after procedure | death for CV cause (MI, stroke) |
| Myocardial infarction (MI) | 9 months after procedure | 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 |
| stent thrombosis (ST) | 9 months after procedure | ST definition: Academic Research Consortium (ARC) definition |
| SB closure | 9 months after procedure | SB closure: TIMI flow \< 3 and/or stenosis \>75% |
Outcome results
None listed