Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent
|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 ]
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|