Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Helistent Titan2 (Titanium coated stent)
EndeavorTM (Zotarolimus-Eluting Stent)
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring Coronary Revascularization, Titanium-Nitride-Oxide Coated Stent, Zotarolimus-Eluting Stent
Eligibility Criteria
Inclusion Criteria:
The following patients are eligible for inclusion
- Age ≥18 years
- Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, unstable angina, and non-ST elevation myocardial infarction
- Presence of one or more coronary artery stenoses >50% in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents;
- No limitation on the number of treated lesions, and vessels, and lesion length
Exclusion Criteria:
- Pregnancy
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, titan, zotarolimus or contrast material
- Inability to provide informed consent
- Currently participating in another trial before reaching first endpoint
- ST segment elevation myocardial infarction (STEMI)
Sites / Locations
- Department of Cardiology, University Hospital Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Titanium Nitride Oxide Coated Stent
Zotarohlimus Eluting Stent
Arm Description
Stent
Stent
Outcomes
Primary Outcome Measures
In-stent late luminal loss
Secondary Outcome Measures
TLR, TVR, Death or MI, CV death or MI, CV death, Death, MI, Stent thrombosis, Stenosis, Restenosis
Full Information
NCT ID
NCT00492908
First Posted
June 25, 2007
Last Updated
April 30, 2014
Sponsor
University of Bern
Collaborators
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT00492908
Brief Title
Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent
Official Title
Randomized Clinical Trial Comparing A Titanium-Nitride-Oxide Coated Stent With A Zotarolimus-Eluting Stent in Patients With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bern
Collaborators
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Randomized Comparison of a Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) With a Zotarolimus-Eluting Stent (EndeavorTm, Medtronic) for Percutaneous Coronary Intervention
Detailed Description
Objectives: The purpose of this study is to compare the Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) with a Zotarolimus-Eluting Stent (EndeavorTm, Medtronic) in a non-inferiority trial.
Design: Prospective, multi-center, randomized, non-inferiority trial to be conducted at 3 Swiss interventional cardiology centers. Patients will be randomized in a single-blind fashion (1:1 randomization) to either the Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) or the Zotarolimus-Eluting Stent (EndeavorTm, Medtronic).
Study Population: Patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, unstable angina, and non-ST elevation myocardial infarction, who qualify for percutaneous coronary interventions
Antiplatelet Therapy: Aspirin 100 mg qd indefinitely; Clopidogrel 75 mg qd for 3 months
Enrollment: A total of 300 patients will be enrolled
All patients will undergo repeat angiography at 6-8 months.
All patients will be followed for up to 5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Coronary Revascularization, Titanium-Nitride-Oxide Coated Stent, Zotarolimus-Eluting Stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Titanium Nitride Oxide Coated Stent
Arm Type
Active Comparator
Arm Description
Stent
Arm Title
Zotarohlimus Eluting Stent
Arm Type
Active Comparator
Arm Description
Stent
Intervention Type
Device
Intervention Name(s)
Helistent Titan2 (Titanium coated stent)
Intervention Description
Titan2
Intervention Type
Device
Intervention Name(s)
EndeavorTM (Zotarolimus-Eluting Stent)
Intervention Description
Endeavor
Primary Outcome Measure Information:
Title
In-stent late luminal loss
Time Frame
6-8 months after stent implantation
Secondary Outcome Measure Information:
Title
TLR, TVR, Death or MI, CV death or MI, CV death, Death, MI, Stent thrombosis, Stenosis, Restenosis
Time Frame
30 days, 6-8 months, 1, 2, 3, 4 and 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The following patients are eligible for inclusion
Age ≥18 years
Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, unstable angina, and non-ST elevation myocardial infarction
Presence of one or more coronary artery stenoses >50% in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents;
No limitation on the number of treated lesions, and vessels, and lesion length
Exclusion Criteria:
Pregnancy
Known intolerance to aspirin, clopidogrel, heparin, stainless steel, titan, zotarolimus or contrast material
Inability to provide informed consent
Currently participating in another trial before reaching first endpoint
ST segment elevation myocardial infarction (STEMI)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Windecker, MD
Organizational Affiliation
Department of Cardiology, University Hospital Bern, Bern, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
15883209
Citation
Windecker S, Simon R, Lins M, Klauss V, Eberli FR, Roffi M, Pedrazzini G, Moccetti T, Wenaweser P, Togni M, Tuller D, Zbinden R, Seiler C, Mehilli J, Kastrati A, Meier B, Hess OM. Randomized comparison of a titanium-nitride-oxide-coated stent with a stainless steel stent for coronary revascularization: the TiNOX trial. Circulation. 2005 May 24;111(20):2617-22. doi: 10.1161/CIRCULATIONAHA.104.486647. Epub 2005 May 9.
Results Reference
background
PubMed Identifier
11514381
Citation
Windecker S, Mayer I, De Pasquale G, Maier W, Dirsch O, De Groot P, Wu YP, Noll G, Leskosek B, Meier B, Hess OM; Working Group on Novel Surface Coating of Biomedical Devices (SCOL). Stent coating with titanium-nitride-oxide for reduction of neointimal hyperplasia. Circulation. 2001 Aug 21;104(8):928-33. doi: 10.1161/hc3401.093146.
Results Reference
background
PubMed Identifier
25572026
Citation
Pilgrim T, Raber L, Limacher A, Wenaweser P, Cook S, Stauffer JC, Garachemani A, Moschovitis A, Meier B, Juni P, Windecker S. Five-year results of a randomised comparison of titanium-nitride-oxide-coated stents with zotarolimus-eluting stents for coronary revascularisation. EuroIntervention. 2015 Mar;10(11):1284-7. doi: 10.4244/EIJY15M01_04.
Results Reference
derived
PubMed Identifier
21700254
Citation
Pilgrim T, Raber L, Limacher A, Loffel L, Wenaweser P, Cook S, Stauffer JC, Togni M, Vogel R, Garachemani A, Moschovitis A, Khattab AA, Seiler C, Meier B, Juni P, Windecker S. Comparison of titanium-nitride-oxide-coated stents with zotarolimus-eluting stents for coronary revascularization a randomized controlled trial. JACC Cardiovasc Interv. 2011 Jun;4(6):672-82. doi: 10.1016/j.jcin.2011.02.017.
Results Reference
derived
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Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent
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