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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: EP: stent strut coverage and stent strut apposition, assessed with OCT at 9 months. EP: restenosis, restenosis at SB ostium, MACE, stent thrombosis.

Official Title
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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.

Conditions
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Coronary Artery Stenosis

Intervention / Treatment
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* Device: AXXESS Biolimus A9-eluting bifurcation stent
* Device: culotte stenting (Xience V)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient older than 18 years Written informed consent available Patient eligible for percutaneous coronary intervention Patients with a de novo and true coronary bifurcation lesion (Medina classification (1,1,1), (1,0,1) or (0,1,1)) Target reference vessel diameter measured by QCA: 2-4 mm Target lesion stenosis measured by QCA: > 70% - < 100% Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations Exclusion Criteria: Left ventricular ejection fraction of < 30% Impaired renal function (serum creatinine > 2.0 mg/dl) Previous and/or planned brachytherapy of target vessel Lesion of the left main trunk > 50%, unprotected Known allergies to antiplatelet, anticoagulation therapy, contrast media or everolimus Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required) Patients with a life expectancy of less than one year Patient currently enrolled in other investigational device or drug trial Patient not able or willing to adhere to follow-up visits Patients who intend to have a major surgical intervention within 6 months of enrolment in the study Patient not able or willing to adhere to follow-up visits Patients who previously participated in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>AXXESS Biolimus A9-eluting bifurcation stent | Device: AXXESS Biolimus A9-eluting bifurcation stent<br>* implantation of stent<br>|
| Active Comparator: 2<br>culotte stenting with use of 2 drug eluting stents | Device: culotte stenting (Xience V)<br>* implantation of stent<br>* Other names: culotte stenting with Xience V;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is % stent strut coverage and % stent strut apposition, assessed with optical coherence tomography, at 9 months follow-up. |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome: Cumulative MACE rate at 1, 8, 9 and 12 months, yearly until 5 years. Separate rates will be provided for: cardiac death, non-fatal myocardial infarction, clinically driven TLR, TVR. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary bifurcation, stent implantation, PCI, Optical Coherence Tomography