Status:
UNKNOWN
Test Safety and Efficacy of Zotarolimus- and Everolimus-Eluting Stents (ZES/EES) Assessed by Optical Coherence Tomography
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of the study is to assess the superiority of the everolimus-eluting stent (Endeavor Resolute®) compared with the everolimus-eluting stent (XIENCE V®) regarding uncovered stent strut segm...
Detailed Description
The mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontin...
Eligibility Criteria
Inclusion
- Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels.
- Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
- In women with childbearing potential a negative pregnancy test is mandatory.
Exclusion
- Lesion length \>16mm requiring a stent length \>18mm
- Target lesion located in the left main trunk.
- In-stent restenosis.
- Acute myocardial infarction
- 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, stainless steel or cobalt chrome.
- Inability to take dual antiplatelet therapy for at least 6 months.
- Pregnancy (present, suspected or planned) or positive pregnancy test.
- Previous enrollment in this trial.
- Patient's inability to fully cooperate with the study protocol.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01230723
Start Date
October 1 2010
End Date
July 1 2012
Last Update
May 8 2012
Active Locations (2)
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1
Deutsches Herzzentrum Muenchen
Munich, Bavaria, Germany, 80636
2
Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675