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Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00492908
First Posted: June 27, 2007
Last Update Posted: May 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital Inselspital, Berne
Information provided by:
University of Bern
  Purpose
A Randomized Comparison of a Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) With a Zotarolimus-Eluting Stent (EndeavorTm, Medtronic) for Percutaneous Coronary Intervention

Condition Intervention Phase
Coronary Heart Disease Device: Helistent Titan2 (Titanium coated stent) Device: EndeavorTM (Zotarolimus-Eluting Stent) Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Bern:

Primary Outcome Measures:
  • In-stent late luminal loss [ Time Frame: 6-8 months after stent implantation ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 303
Study Start Date: June 2007
Study Completion Date: August 2013
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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

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)
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Switzerland
Department of Cardiology, University Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Stephan Windecker, MD Department of Cardiology, University Hospital Bern, Bern, Switzerland
  More Information

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 Submitted: June 25, 2007
First Posted: June 27, 2007
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


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