Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent

This study has been completed.
Sponsor:
Collaborator:
University Hospital Inselspital, Berne
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT00492908
First received: June 25, 2007
Last updated: April 30, 2014
Last verified: April 2014

June 25, 2007
April 30, 2014
June 2007
March 2009   (final data collection date for primary outcome measure)
In-stent late luminal loss [ Time Frame: 6-8 months after stent implantation ] [ Designated as safety issue: No ]
In-stent late luminal loss [ Time Frame: 6-8 months after stent implantation ]
Complete list of historical versions of study NCT00492908 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
TLR, TVR, Death or MI, CV death or MI, CV death, Death, MI, Stentthrombosis, Stenosis, Restenosis [ Time Frame: 30 days, 6-8 months, 1, 2, 3, 4 and 5 years ]
Not Provided
Not Provided
 
Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent
Randomized Clinical Trial Comparing A Titanium-Nitride-Oxide Coated Stent With A Zotarolimus-Eluting Stent in Patients With Coronary Artery Disease

A Randomized Comparison of a Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) With a Zotarolimus-Eluting Stent (EndeavorTm, Medtronic) for Percutaneous Coronary Intervention

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Coronary Heart Disease
  • Device: Helistent Titan2 (Titanium coated stent)
    Titan2
  • Device: EndeavorTM (Zotarolimus-Eluting Stent)
    Endeavor
  • Active Comparator: Titanium Nitride Oxide Coated Stent
    Stent
    Intervention: Device: Helistent Titan2 (Titanium coated stent)
  • Active Comparator: Zotarohlimus Eluting Stent
    Stent
    Intervention: Device: EndeavorTM (Zotarolimus-Eluting Stent)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
303
August 2013
March 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00492908
KEK237_06
No
Department of Cardiology, Bern University Hospital
University of Bern
University Hospital Inselspital, Berne
Principal Investigator: Stephan Windecker, MD Department of Cardiology, University Hospital Bern, Bern, Switzerland
University of Bern
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP