Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent

Phase 4

Completed

• Conditions: Coronary Heart Disease
• Interventions: Device: EndeavorTM (Zotarolimus-Eluting Stent); Device: Helistent Titan2 (Titanium coated stent)

• Registration Number: NCT00492908
• Lead Sponsor: University of Bern

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-25
• Study First Submitted QC: 2007-06-25
• Study First Posted: 2007-06-27
• Primary Completion: 2009-03
• Study Completion: 2013-08
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-30
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zotarohlimus Eluting Stent	EndeavorTM (Zotarolimus-Eluting Stent)	Stent
Titanium Nitride Oxide Coated Stent	Helistent Titan2 (Titanium coated stent)	Stent

Primary Outcome Measures

Name	Time	Method
In-stent late luminal loss	6-8 months after stent implantation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Cardiology, University Hospital Bern; 🇨🇭 Bern, Switzerland