Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent

University of Bern

Status and phase: Completed; Phase 4

Conditions: Coronary Heart Disease

Treatments: Device: EndeavorTM (Zotarolimus-Eluting Stent); Device: Helistent Titan2 (Titanium coated stent)

Study type: Interventional

Funder types: Other

Identifiers

NCT00492908

KEK237_06

Details and patient eligibility

About

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

Full 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.

Enrollment: 303 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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303 participants in 2 patient groups

Titanium Nitride Oxide Coated Stent

Active Comparator group

Description:

Stent

Treatment:

Device: Helistent Titan2 (Titanium coated stent)

Zotarohlimus Eluting Stent

Active Comparator group

Description:

Stent

Treatment:

Device: EndeavorTM (Zotarolimus-Eluting Stent)