Back to resultsTest Safety and Efficacy of Zotarolimus- and Everolimus-Eluting Stents (ZES/EES) Assessed by Optical Coherence Tomography (ZES/EES-OCT)
Primary Purpose
Coronary Heart Disease
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Everolimus-Eluting-Stent
Zotarolimus-Eluting-Stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Deutsches Herzzentrum Muenchen
- Klinikum rechts der Isar
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Everolimus-Eluting Stent
Zotarolimus-Eluting-Stent
Outcomes
Primary Outcome Measures
Degree of stent strut coverage assessed by OCT for each visible strut segment
Secondary Outcome Measures
Percentage of malapposed strut assessed by OCT
Percentage of uncovered malapposed struts assessed by OCT
Full Information
NCT ID
NCT01230723
First Posted
October 28, 2010
Last Updated
May 7, 2012
Sponsor
Deutsches Herzzentrum Muenchen
1. Study Identification
Unique Protocol Identification Number
NCT01230723
Brief Title
Test Safety and Efficacy of Zotarolimus- and Everolimus-Eluting Stents (ZES/EES) Assessed by Optical Coherence Tomography
Acronym
ZES/EES-OCT
Official Title
RANDOMIZED TRIAL OF ZOTAROLIMUS- AND EVEROLIMUS-ELUTING STENTS REGARDING STENT COVERAGE ASSESSED BY OCT
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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 discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based DES. The extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. The optical coherence tomography (OCT) is an intravascular imaging modality based on light. The principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Everolimus-Eluting Stent
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Zotarolimus-Eluting-Stent
Intervention Type
Device
Intervention Name(s)
Everolimus-Eluting-Stent
Other Intervention Name(s)
Xience-V®
Intervention Description
due randomization everolimus-eluting-stent will be implanted
Intervention Type
Device
Intervention Name(s)
Zotarolimus-Eluting-Stent
Other Intervention Name(s)
Endeavor Resolute®
Intervention Description
due randomization zotarolimus-eluting-stent will be implanted
Primary Outcome Measure Information:
Title
Degree of stent strut coverage assessed by OCT for each visible strut segment
Time Frame
6-8 months
Secondary Outcome Measure Information:
Title
Percentage of malapposed strut assessed by OCT
Time Frame
6-8 months
Title
Percentage of uncovered malapposed struts assessed by OCT
Time Frame
6-8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Tiroch, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80636
Country
Germany
Facility Name
Klinikum rechts der Isar
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Test Safety and Efficacy of Zotarolimus- and Everolimus-Eluting Stents (ZES/EES) Assessed by Optical Coherence Tomography
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