A Phase 4 interventional study of OCT-guided PCI with AXXESS stent and OCT-guided PCI with conventional DES (Biomatrix flex stent) in Coronary Bifurcation Lesions, sponsored by Yonsei University. Withdrawn. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-07-27.
Sponsored by Yonsei University · Phase 4, Interventional, and Treatment
Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AXXESS stent (OCT-guided)
Device: OCT-guided PCI with AXXESS stent
Conventional DES (Biomatrix flex stent, OCT-guided)
Device: OCT-guided PCI with conventional DES (Biomatrix flex stent)
AXXESS stent (Angio-guided)
Device: Angio-guided PCI with AXXESS stent
Conventional DES (Biomatrix flex stent, Angio-guided)
Device: Angio-guided PCI with PCI with conventional DES (Biomatrix flex 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.
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.
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.
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.
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)
Time frame: 9 months after procedure
Cardiovascular (CV) death
death for CV cause (MI, stroke)
Time frame: 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
Time frame: 9 months after procedure
stent thrombosis (ST)
ST definition: Academic Research Consortium (ARC) definition
Time frame: 9 months after procedure
SB closure
SB closure: TIMI flow \< 3 and/or stenosis \>75%
Time frame: 9 months after procedure
No study locations are listed for this record.
This study is withdrawn, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yonsei University