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

Coronary Bifurcation Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02384629
• Other study ID #: 1-2014-0079
• Status: Withdrawn
• Phase: Phase 4
• First received: March 4, 2015
• Last updated: July 26, 2016
• Start date: March 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Bifurcation Lesions

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cardiovascular (CV) death	death for CV cause (MI, stroke)	9 months after procedure	Yes
Secondary	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	Yes
Secondary	stent thrombosis (ST)	ST definition: Academic Research Consortium (ARC) definition	9 months after procedure	Yes
Secondary	SB closure	SB closure: TIMI flow < 3 and/or stenosis >75%	9 months after procedure	Yes