A Trial Comparing a Paclitaxel Eluting Stent With Biodegradable Polymer Versus a Bare Metal Stent

Study Overview
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Brief Summary
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The success of stent implantation has led to the increasingly widespread use of them in the treatment of coronary artery disease (Sigwart, Serruys, Fischman)and although stent restenosis is still a limit for this therapeutic mode (Serruys, Rodriguez) the new generation of stents with improved coating materials and the development of polymers that release different kinds of drugs that prevent the activation and/or proliferation of smooth muscle cells (ultimate cause of restenosis) (Grube, Rodriguez). shows major improvements on this matter. The new generation of stents with biodegradable polymers and short time of drug release gives new advantages to this therapeutic, multiple studies and registries challenge this new devices (Taxus I and II, RAVEL, SIRIUS, ERACI II and III). For this reason the present study aims to compare a stainless steel stent with a drug eluting stent with coated of biodegradable polymer matrix hemoparin and paclitaxel.

Detailed Description
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Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina were randomized to treat with a stainless steel stent (euca STS Flex) or a drug-eluting stent ( euca STS Flex DE) with a coating of a biodegradable polymer matrix of hemoparin and paclitaxel.

Official Title
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Comparison Among a Paclitaxel Eluting Stent With Biodegradable Polymer Versus an Uncoated Bare Metal Stent. A Prospective, Multicentric and Randomized Study.(EUCATAX Trial)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Bare Metal Stent
* Device: Drug Eluting Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient signing informed consent after receiving extensive written and oral information about the trial, Older than 18 years, Agreement to have a control examination done after six months, Patients with angina pectoris symptoms (CCS stages i-IV, unstable angina pectoris Braunwald B and C) and patients with documented silent ischemia; Patients with one or more de novo lesions which all are to be dilated in the same session; Target vessel diameter of 2.5 to 4.0 mm Exclusion Criteria: Female patients of child bearing age with pregnancy suspicion(a pregnancy test will be done in this cases) Acute myocardial infarction (Q wave or non Q wave ) with documented CK levels more than 2 fold higher than the normal values in the preceding 72 hours , Substantially calcified lesion precluding successful pre dilatation, Ejection Fraction less than 35%, Patient with previous PCI with one DES, Target lesion < 2.5 mm Coagulopathy or clotting disorders, leucopenia anemia or thrombocytopenia, Allergy, hypersensitivity or adverse reaction to paclitaxel, Intolerance to the clopidogrel, Ticlopidine or Aspirin or unable to receive clopidogrel for one year, Active duodenal or gastric ulcer, Life Expectancy less than 1 year, Patient with LM disease (>50%)

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1-BMS<br>Bare Metal Stent (Euca STS Flex) | Device: Bare Metal Stent<br>* Stainless steel stent<br>* Other names: Euca STS Flex;|
| Experimental: 2-DES<br>Drug Eluting Stent (Euca STS Flex DE), Paclitaxel Eluting stent with biodegradable polymer | Device: Drug Eluting Stent<br>* stent coated with the biodegradable polymer matrix hemoparin and paclitaxel<br>* Other names: Euca STS Flex DE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Failure |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent thrombosis |  | one year | 
| Paclitaxel allergy |  | six months | 
| Cost-effectiveness |  | one year | 
| Quantitative Coronary Angiography |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biodegradable polymer, Drug Eluting Stent, In stent restenosis, stent thrombosis, Bare Metal Stent