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

Phase 4

Withdrawn

• Conditions: Coronary Bifurcation Lesions
• Interventions: Device: OCT-guided PCI with AXXESS stent; Device: Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent); Device: Angio-guided PCI with AXXESS stent; Device: OCT-guided PCI with conventional DES (Biomatrix flex stent)

• Registration Number: NCT02384629
• Lead Sponsor: Yonsei University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27
• Primary Completion: 2017-03
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXXESS stent1	OCT-guided PCI with AXXESS stent	AXXESS stent (OCT-guided)
Conventional DES2	Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent)	Conventional DES (Biomatrix flex stent, Angio-guided)
AXXESS stent2	Angio-guided PCI with AXXESS stent	AXXESS stent (Angio-guided)
Conventional DES1	OCT-guided PCI with conventional DES (Biomatrix flex stent)	Conventional DES (Biomatrix flex stent, OCT-guided)

Primary Outcome Measures

Name	Time	Method
Late loss of side branch(SB)	9 months after procedure	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)

Secondary Outcome Measures

Name	Time	Method
Cardiovascular (CV) death	9 months after procedure	death for CV cause (MI, stroke)
Myocardial infarction (MI)	9 months after procedure	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
stent thrombosis (ST)	9 months after procedure	ST definition: Academic Research Consortium (ARC) definition
SB closure	9 months after procedure	SB closure: TIMI flow \< 3 and/or stenosis \>75%