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

NCT02384629 | Withdrawn Phase 4 DMC

• 1 other identifier: 1-2014-0079
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.To compare the safety and efficacy of AXXESS stent with conventional DES in patients with coronary artery bifurcation disease
2. 2.To assess the impact of optical coherence tomography (OCT) guidance on clinical outcomes following the stent type

Conditions

Coronary Bifurcation Lesions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cardiovascular (CV) death

  9 months after procedure

• Myocardial infarction (MI)

  9 months after procedure

• stent thrombosis (ST)

  9 months after procedure

• SB closure

  9 months after procedure

Study Arms (4)

AXXESS stent1

EXPERIMENTAL

AXXESS stent (OCT-guided)

Device: OCT-guided PCI with AXXESS stent

Conventional DES1

EXPERIMENTAL

Conventional DES (Biomatrix flex stent, OCT-guided)

Device: OCT-guided PCI with conventional DES (Biomatrix flex stent)

AXXESS stent2

ACTIVE COMPARATOR

AXXESS stent (Angio-guided)

Device: Angio-guided PCI with AXXESS stent

Conventional DES2

ACTIVE COMPARATOR

Conventional DES (Biomatrix flex stent, Angio-guided)

Device: Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent)

Interventions

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.

AXXESS stent1

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.

Conventional DES1

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.

AXXESS stent2

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.

Conventional DES2

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures,
• Patients ≥ 19 years old,
• Patients who are expected to undergo PCI for bifurcation lesions.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 10, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 27, 2016

Record last verified: 2016-07