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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Department of Cardiology, Bern University Hospital
ClinicalTrials.gov Identifier: NCT00492908     History of Changes
Other Study ID Numbers: KEK237_06
Study First Received: June 25, 2007
Last Updated: April 30, 2014
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University of Bern:
Coronary Revascularization
Titanium-Nitride-Oxide Coated Stent
Zotarolimus-Eluting Stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 26, 2014