Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Assessed By Optical Coherence Tomography

Study Overview
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Brief Summary
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The purpose of the trial is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neoin-timal formation) to the bio-active-stent (BAS) versus ever-olimus-eluting stent (EES) implanted for the treatment of the culprit lesion in acute coronary syndrome.

Detailed Description
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A prospective, randomized and controlled study comparing the coverage of the BAS and EES implanted in acute coronary syndrome. Clinical follow-up at 1, 6, 12 and 18 months. OCT analysis at the time of the 6 to 8 months follow-up.

Official Title
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Early Coverage and Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Implanted in Acute Coronary Syndrome Assessed By Optical Coherence Tomography (BASE-OCT)

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: OCT
* Device: OCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 18 years old; The patient is presenting with acute coronary syndrome, and according to hospital routine practice, eligible for percutaneous coronary intervention; Patient or the patient's legal representative has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Ethics Committee of the respective clinical site. Exclusion Criteria: Lesions in coronary artery bypass grafts Left main disease Killip class III-IV Allergy to aspirin / thienopyridine Patient in anticoagulation therapy No suitable anatomy for OCT scan Ostial lesion Tortuosity anatomy Very distal lesion Vessel size > 3.75 mm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BAS<br>Patient's receiving BAS | Device: OCT<br>* Optical coherence tomography<br>* Other names: TITAN-2, Hexacath, France;|
| EES<br>Patients receiving EES | Device: OCT<br>* Optical coherence tomography<br>* Other names: Xience-V, Abbott vascular, USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncovered stent struts | OCT number of uncovered stent struts for BAS versus EES. | 6-8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death,MI, stent thrombosis (ST) and TLR. | Device oriented composite endpoint, defined as cardiac death,MI, stent thrombosis (ST) and TLR at at 1, 6, 12 and 18 months. | 1, 6, 12 and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pci, titanium, everolimus, oct, acute coronary syndrome, stent, stenting