Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent
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ClinicalTrials.gov Identifier: NCT00492908 |
Recruitment Status
:
Completed
First Posted
: June 27, 2007
Last Update Posted
: May 1, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Heart Disease | Device: Helistent Titan2 (Titanium coated stent) Device: EndeavorTM (Zotarolimus-Eluting Stent) | Phase 4 |
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 (Clinical Trial) |
Actual Enrollment : | 303 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized Clinical Trial Comparing A Titanium-Nitride-Oxide Coated Stent With A Zotarolimus-Eluting Stent in Patients With Coronary Artery Disease |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | August 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Titanium Nitride Oxide Coated Stent
Stent
|
Device: Helistent Titan2 (Titanium coated stent)
Titan2
|
Active Comparator: Zotarohlimus Eluting Stent
Stent
|
Device: EndeavorTM (Zotarolimus-Eluting Stent)
Endeavor
|
- In-stent late luminal loss [ Time Frame: 6-8 months after stent implantation ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- Pregnancy
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492908
Switzerland | |
Department of Cardiology, University Hospital Bern | |
Bern, Switzerland, 3010 |
Principal Investigator: | Stephan Windecker, MD | Department of Cardiology, University Hospital Bern, Bern, Switzerland |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Department of Cardiology, Bern University Hospital |
ClinicalTrials.gov Identifier: | NCT00492908 History of Changes |
Other Study ID Numbers: |
KEK237_06 |
First Posted: | June 27, 2007 Key Record Dates |
Last Update Posted: | May 1, 2014 |
Last Verified: | April 2014 |
Keywords provided by University of Bern:
Coronary Revascularization Titanium-Nitride-Oxide Coated Stent Zotarolimus-Eluting Stent |
Additional relevant MeSH terms:
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Sirolimus |
Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antineoplastic Agents Antifungal Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |