Randomized Clinical Trial Comparing A Titanium-Nitride-Oxide Coated Stent With A Zotarolimus-Eluting Stent in Patients With Coronary Artery Disease
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- University of Bern
- Enrollment
- 303
- Locations
- 1
- Primary Endpoint
- In-stent late luminal loss
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •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)
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(30 days, 6-8 months, 1, 2, 3, 4 and 5 years)