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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
Sponsor:
Collaborator:
University Hospital Inselspital, Berne
Information provided by:
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

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

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 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

Resource links provided by the National Library of Medicine


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




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

Secondary Outcome Measures :
  1. 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, Older Adult)
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)

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

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