Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent

University of Bern303 enrolled

Overview

A Randomized Comparison of a Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) With a Zotarolimus-Eluting Stent (EndeavorTm, Medtronic) for Percutaneous Coronary Intervention

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

303

Conditions

Coronary Heart Disease

Interventions

Helistent Titan2 (Titanium coated stent)DEVICE

Titan2

EndeavorTM (Zotarolimus-Eluting Stent)DEVICE

Endeavor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: The following patients are eligible for inclusion 1. Age ≥18 years 2. Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, unstable angina, and non-ST elevation myocardial infarction 3. 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; 4. No limitation on the number of treated lesions, and vessels, and lesion length Exclusion Criteria: 1. Pregnancy 2. Known intolerance to aspirin, clopidogrel, heparin, stainless steel, titan, zotarolimus or contrast material 3. Inability to provide informed consent 4. Currently participating in another trial before reaching first endpoint 5. ST segment elevation myocardial infarction (STEMI)

Locations (1)

Department of Cardiology, University Hospital Bern

Bern, Switzerland

Outcomes

Primary Outcomes

In-stent late luminal loss

Time frame: 6-8 months after stent implantation

Secondary Outcomes

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

Data from ClinicalTrials.gov

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