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COmplex BifuRcation Lesions: A Comparison Between the AXXESS Device and Culotte Stenting: An Optical Coherence Tomography (OCT) Study — COBRA  

Coronary Artery Stenosis Clinical Trial

Official title:
Comparison of Healing Responses After Treatment of Complex Bifurcation Lesions With the AXXESS Biolimus A9 Eluting Stent Versus Culotte Technique Using Everolimus-eluting Stents: an Optical Coherence Tomography Analysis.

Clinical Trial Summary

The aim of this study is to compare vessel healing at 9 months using OCT imaging for two different treatment techniques for treating bifurcation lesions. Quantitative assessment of OCT images will be used to assess re-endothelialization and quality of strut apposition to the vessel wall.

Clinical Trial Description

Background: There is an ongoing controversy over the efficacy and safety of different bifurcation stenting techniques. Critical considerations are the rate of restenosis at the side branch ostium, and completeness of healing at sites of overlap of stent struts, which may affect the risk of stent thrombosis. Methods: Patients with complex bifurcation lesions with involvement of a significant side branch requiring a stent are randomized into two treatment arms. The first group of 20 patients (group I) is treated with the AXXESS Biolimus A9 Bifurcation Stent System (Devax, Inc, Lake Forest CA), where additional everolimus-eluting Xience V stents (Abbott Vascular, Santa Clara, CA) are implanted into the distal main branch and the side branch as required. The second group of 20 patients (group II) is treated with the culotte technique using everolimus-eluting Xience V stents. Kissing balloon dilatation using non-compliant balloons will complete the index procedure in all cases. At 9 months, control angiography (with QCA using dedicated software) and OCT (of both main vessel and side branch) is performed. Assessment of Results: 1. EP: stent strut coverage and stent strut apposition, assessed with OCT at 9 months. 2. EP: restenosis, restenosis at SB ostium, MACE, stent thrombosis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00895791
Study type Interventional
Source Universitaire Ziekenhuizen KU Leuven
Contact
Status Withdrawn
Phase N/A
Start date June 2009
Completion date December 2015
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