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

Yonsei University

Status and phase: Withdrawn; Phase 4

Conditions: Coronary Bifurcation Lesions

Treatments: Device: Angio-guided PCI with AXXESS stent; Device: Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent); Device: OCT-guided PCI with conventional DES (Biomatrix flex stent); Device: OCT-guided PCI with AXXESS stent

Study type: Interventional

Funder types: Other

Identifiers

NCT02384629

1-2014-0079

Details and patient eligibility

About

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

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 4 patient groups

AXXESS stent1

Experimental group

Description:

AXXESS stent (OCT-guided)

Treatment:

Device: OCT-guided PCI with AXXESS stent

Conventional DES1

Experimental group

Description:

Conventional DES (Biomatrix flex stent, OCT-guided)

Treatment:

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

AXXESS stent2

Active Comparator group

Description:

AXXESS stent (Angio-guided)

Treatment:

Device: Angio-guided PCI with AXXESS stent

Conventional DES2

Active Comparator group

Description:

Conventional DES (Biomatrix flex stent, Angio-guided)

Treatment:

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