Status:
UNKNOWN
Zotarolimus and Everolimus-Eluting Stents ProsPectively Compared in Real World
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The zotarolimus-eluting Endeavor Resolute stent is not inferior to the everolimus- eluting Xience V stent platform regarding a composite of cardiac death, myocardial infarction or target lesion revasc...
Detailed Description
The use of stents has become common practice in the percutaneous treatment of coronary artery disease. Restenosis affected 20-40% of de novo coronary lesions treated with bare metal stents. Drug-eluti...
Eligibility Criteria
Inclusion
- Patients older than 18 years with symptomatic coronary artery disease undergoing PCI with stent implantation.
- Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
Exclusion
- Cardiogenic shock.
- Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
- Known allergy to the study medications: everolimus, zotarolimus, cobalt chrome.
- Inability to take clopidogrel for at least 6 months.
- Pregnancy (present, suspected or planned) or positive pregnancy test. (In women with childbearing potential a pregnancy test is mandatory.)
- Previous enrollment in this trial.
- Patient's inability to fully cooperate with the study protocol.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
2600 Patients enrolled
Trial Details
Trial ID
NCT00768846
Start Date
September 1 2008
End Date
June 1 2011
Last Update
October 15 2008
Active Locations (2)
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1
1st Medizinische Klinik Klinikum rechts der Isar
Munich, Germany, 81675
2
Deutsches Herzzentrum Munich
Munich, Germany, 81675