Optical Coherence Tomography Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease

Study Overview
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Brief Summary
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A prospective Optical Coherence Tomography (OCT) study on the completeness of strut coverage and vessel wall response, at different time points (3-6-9 Months), following TAXUS Liberte stent implantation (staged procedures) in patients with multi vessel native coronary artery lesions

Detailed Description
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Major concerns were addressed to the delayed healing process of drug-eluting stents in off-label indications. To date no studies have detailed the in-vivo completeness of DES coverage at different time points. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (neointima disomogeneity, acquired late incomplete strut apposition) at different time points following paclitaxel-eluting stent implantation, in patients with multivessel disease treated with staged PCI procedures. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at different time point. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and 9 months elective follow-up.

Official Title
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A Prospective Optical Coherence Tomography Study on Completeness of Strut Coverage and Vessel Wall Response at 3-6 and 9 Months Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Taxus Libertè™ paclitaxel drug-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multivessel coronary artery disease (two or 3 VD) to be treated at 2 sequences (staged procedures) with paclitaxel-polymer eluting stents Native coronary artery disease with >= 75% diameter stenosis Vessel size in between 2.5 and 3.5 mm. Written informed consent signed Exclusion Criteria: No suitable anatomy for OCT scan: (truly ostial , tortuous anatomy, very distal lesions or vessels larger than 3.75 in reference diameter). significant left main coronary artery disease, lesions in bypass grafts, acute myocardial infarction, poor cardiac function as defined by left ventricular ejection fraction ≤ 30%. allergy to aspirin and or clopidogrel/ticlopidine, Renal failure with creatinine value > 2.5 mg/dl

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Device, paclitaxel drug-eluting stent | Device: Taxus Libertè™ paclitaxel drug-eluting stent<br>* device:Taxus Libertè™ (Boston Scientific,Natick,MS)assessed at different time points after implant<br>* Other names: Taxus Libertè™ (Boston Scientific,Natick,MS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of uncovered and/or malapposed Taxus Libertè struts at different time point after the implant, as measured by OCT |  | 3-6-9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Incomplete apposition at different point of FU (3-6-9 months) |  | 3-6-9 months | 
| Proportion of neointima disomogeneity around struts at different point of FU (3-6-9 months) |  | 3-6-9 months | 
| OCT Neointima thickness overtime |  | 3-6-9 months | 
| Ischemia Driven Target Vessel Failure (ID-TVF) rate at 12 months |  | 12 months | 
| Adjudicated MACE rate at 30 days and 12 months |  | 30 days and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Eluting Stents, Percutaneous Coronary Interventions, Optical Coherence Tomography