Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent
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|ClinicalTrials.gov Identifier: NCT00492908|
Recruitment Status : Completed
First Posted : June 27, 2007
Last Update Posted : May 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease||Device: Helistent Titan2 (Titanium coated stent) Device: EndeavorTM (Zotarolimus-Eluting Stent)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||303 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Clinical Trial Comparing A Titanium-Nitride-Oxide Coated Stent With A Zotarolimus-Eluting Stent in Patients With Coronary Artery Disease|
|Study Start Date :||June 2007|
|Primary Completion Date :||March 2009|
|Study Completion Date :||August 2013|
Active Comparator: Titanium Nitride Oxide Coated Stent
Device: Helistent Titan2 (Titanium coated stent)
Active Comparator: Zotarohlimus Eluting Stent
Device: EndeavorTM (Zotarolimus-Eluting Stent)
- In-stent late luminal loss [ Time Frame: 6-8 months after stent implantation ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492908
|Department of Cardiology, University Hospital Bern|
|Bern, Switzerland, 3010|
|Principal Investigator:||Stephan Windecker, MD||Department of Cardiology, University Hospital Bern, Bern, Switzerland|