Late Incomplete Stent Apposition Evaluation II: Comparison Between Polimer-based and No-polimer Stent System. IVUS Based Study

Study Overview
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Brief Summary
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Vascular effects evaluation after non-polimeric and polimeric paclitaxel stent implantation.In particular the investigators will use Taxus )as a polimeric stent)and Axxion (as a non-polimeirc)stent system. The investigators will look at late stent malapposition by means of intracoronary ultrasound imaging technique (IVUS) at baseline and 9 months follow-up. The investigators sought to compare the two stent types with the same drug to verify the polimer role. The polimer itself seems to provoke inflammation and hypersensibility if the arterial wall and it seems to be the base of a process of positive remodeling found at drug eluting stent implantation site. This positive remodeling is the mechanism producing late stent malapposition which on its turn can determine stent thrombosis, as demonstrated by pathological studies. At the same time the investigators will study the incidence of clinical events like myocardial infarction, stent thrombosis, TLR and death along with the incidence of angiographic restenosis at 2 years follow up.

Official Title
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Late Incomplete Stent Apposition Evaluation II: Vascular Effects Evaluation After Polimer and No-polimer Based Coronary Artery Drug Eluting Stent Ilmplantation. An IVUS Based Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Percutaneous transluminal Coronary Angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with coronary artery stenosis in one, two or three vessels, and with objective evidence of isquemia. The stenosis must allow IVUS analisis, must be treatable with angioplasty with stent Target Vessel diameter must be between 2.25- 4 mm with QCA. Patients must sign informed consent Patients and their physician must accept the angiographic follow-up Exclusion Criteria: 18 years old patients SCA within the last 72 hours, or patients with CK twice over the upper normal limit Pregnancy Target vessel diameter < 2.25 or > 4 mm by QCA Previous brakitherapy or DES in the target lesion Restenotic lesion -Allergy to aspirin, clopidogrel or ticlopidin Patients enrolled in other studies or trials By-pass graft lesions Real bifurcationa lesions Severe Renal insufficiency (creatinin clearance < 30 ml/min). Severe Liver failure(GOT y GPT > 3 times the upper normal limit) Life expectancy < 1 year because of other pathologies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Polimeric-PES<br>Arm receiving polimeric stent (Taxus) | Procedure: Percutaneous transluminal Coronary Angioplasty<br>* Coronary artery stent implantation<br>|
| Active Comparator: Non-Polimeric PES<br>Arm receiving non-polimeric PES (axxion) | Procedure: Percutaneous transluminal Coronary Angioplasty<br>* Coronary artery stent implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra coronary ultrasound analysis to verify stent malapposition at follow-up |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical events (myocardial infarction, TLR,at 1, 9, 12, 24 months follow-up:; Incidence of restenosis with QCA at 9 months follow-up Intimal hiperplasia measured by IVUS at 9 months follow-up; Stent Thrombosis. |  | 9 months and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Late stent malapposition, stent thrombosis, IVUS, non-polimeric stent