Zotarolimus and Everolimus-Eluting Stents ProsPectively Compared in Real World
ZEPPELIN
Randomized Comparison of Zotarolimus- and Everolimus-Eluting Stents for Coronary Treatment
1 other identifier
interventional
2,600
1 country
2
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 revascularisation in a real-world population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Sep 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 6, 2008
CompletedFirst Posted
Study publicly available on registry
October 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedOctober 15, 2008
October 1, 2008
1.7 years
October 6, 2008
October 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A composite of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation
1 year after randomization
Secondary Outcomes (4)
Late luminal loss
6-8 months
Binary angiographic restenosis
6-8 months
All cause mortality
1 year
Stent thrombosis
1 year
Study Arms (2)
1
ACTIVE COMPARATOREndeavor Resolute Stent
2
ACTIVE COMPARATORXience V Stent
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
1st Medizinische Klinik Klinikum rechts der Isar
Munich, 81675, Germany
Deutsches Herzzentrum Munich
Munich, 81675, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Adnan Kastrati, MD
Deutsches Herzzentrum Munich
- PRINCIPAL INVESTIGATOR
Julinda Mehilli, MD
Deutsches Herzzentrum Munich
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 6, 2008
First Posted
October 8, 2008
Study Start
September 1, 2008
Primary Completion
May 1, 2010
Study Completion
June 1, 2011
Last Updated
October 15, 2008
Record last verified: 2008-10