Test Safety and Efficacy of Zotarolimus- and Everolimus-Eluting Stents (ZES/EES) Assessed by Optical Coherence Tomography
ZES/EES-OCT
RANDOMIZED TRIAL OF ZOTAROLIMUS- AND EVEROLIMUS-ELUTING STENTS REGARDING STENT COVERAGE ASSESSED BY OCT
1 other identifier
interventional
30
1 country
2
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 segments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 28, 2010
CompletedFirst Posted
Study publicly available on registry
October 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedMay 8, 2012
May 1, 2012
1.2 years
October 28, 2010
May 7, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Degree of stent strut coverage assessed by OCT for each visible strut segment
6-8 months
Secondary Outcomes (2)
Percentage of malapposed strut assessed by OCT
6-8 months
Percentage of uncovered malapposed struts assessed by OCT
6-8 months
Study Arms (2)
Arm 1
ACTIVE COMPARATOREverolimus-Eluting Stent
Arm 2
ACTIVE COMPARATORZotarolimus-Eluting-Stent
Interventions
due randomization everolimus-eluting-stent will be implanted
due randomization zotarolimus-eluting-stent will be implanted
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Deutsches Herzzentrum Muenchen
Munich, Bavaria, 80636, Germany
Klinikum rechts der Isar
Munich, Bavaria, 81675, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus Tiroch, MD
Deutsches Herzzentrum Muenchen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2010
First Posted
October 29, 2010
Study Start
October 1, 2010
Primary Completion
December 1, 2011
Study Completion
July 1, 2012
Last Updated
May 8, 2012
Record last verified: 2012-05