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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00492908

Enrollment

303

Registered

2007-06-27

Start date

2007-06-30

Completion date

2013-08-31

Last updated

2014-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

Coronary Revascularization, Titanium-Nitride-Oxide Coated Stent, Zotarolimus-Eluting Stent

Brief 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.

Interventions

DEVICEHelistent Titan2 (Titanium coated stent)

Titan2

DEVICEEndeavorTM (Zotarolimus-Eluting Stent)

Endeavor

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
In-stent late luminal loss	6-8 months after stent implantation

Secondary

Measure	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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026