Status:
COMPLETED
A Trial Comparing a Paclitaxel Eluting Stent With Biodegradable Polymer Versus a Bare Metal Stent
Lead Sponsor:
Centro de estudios en Cardiologia Intervencionista
Collaborating Sponsors:
Eucatech AG
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
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 li...
Detailed Description
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 Fl...
Eligibility Criteria
Inclusion
- 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
- 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%)
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00825279
Start Date
August 1 2007
End Date
August 1 2009
Last Update
May 28 2010
Active Locations (2)
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1
Clinica IMA
Adrogué, Buenos Aires, Argentina, 1846
2
Sanatorio Otamendi y Miroli
Buenos Aires, Buenos Aires, Argentina, 1115