PCI With AXXESS Biolimus A9 Eluting Bifurcation Stent in Treating Coronary Artery Bifurcation Disease

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

Study Overview

• Status: Withdrawn
• Conditions: Coronary Bifurcation Lesions
• Intervention / Treatment: Device: OCT-guided PCI with AXXESS stent; Device: OCT-guided PCI with conventional DES (Biomatrix flex stent); Device: Angio-guided PCI with AXXESS stent; Device: Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent)

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AXXESS stent1; AXXESS stent (OCT-guided)	Device: OCT-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.
EXPERIMENTAL: Conventional DES1; Conventional DES (Biomatrix flex stent, OCT-guided)	Device: OCT-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.
ACTIVE_COMPARATOR: AXXESS stent2; AXXESS stent (Angio-guided)	Device: Angio-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.
ACTIVE_COMPARATOR: Conventional DES2; Conventional DES (Biomatrix flex stent, Angio-guided)	Device: Angio-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (ANTICIPATED): March 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (ESTIMATE): March 10, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 26, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 1-2014-0079