NCT00492908

Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent

Randomized Clinical Trial Comparing A Titanium-Nitride-Oxide Coated Stent With A Zotarolimus-Eluting Stent in Patients With Coronary Artery Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: University of Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DEVICE	Helistent Titan2 (Titanium coated stent)	Titan2
DEVICE	EndeavorTM (Zotarolimus-Eluting Stent)	Endeavor

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-03-01
• Completion: 2013-08-01
• First posted: 2007-06-27
• Last updated: 2014-05-01

Locations

1 site across 1 country: Switzerland