Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: Helistent Titan2 (Titanium coated stent)
* Device: EndeavorTM (Zotarolimus-Eluting Stent)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Titanium Nitride Oxide Coated Stent<br>Stent | Device: Helistent Titan2 (Titanium coated stent)<br>* Titan2<br>|
| Active Comparator: Zotarohlimus Eluting Stent<br>Stent | Device: EndeavorTM (Zotarolimus-Eluting Stent)<br>* Endeavor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent late luminal loss |  | 6-8 months after stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TLR, TVR, Death or MI, CV death or MI, CV death, Death, MI, Stent thrombosis, Stenosis, Restenosis |  | 30 days, 6-8 months, 1, 2, 3, 4 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Revascularization, Titanium-Nitride-Oxide Coated Stent, Zotarolimus-Eluting Stent