Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent - Full Text View

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:

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

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 (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

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:

Windecker S, Simon R, Lins M, Klauss V, Eberli FR, Roffi M, Pedrazzini G, Moccetti T, Wenaweser P, Togni M, Tüller D, Zbinden R, Seiler C, Mehilli J, Kastrati A, Meier B, Hess OM. Randomized comparison of a titanium-nitride-oxide-coated stent with a stainless steel stent for coronary revascularization: the TiNOX trial. Circulation. 2005 May 24;111(20):2617-22. Epub 2005 May 9.

Windecker S, Mayer I, De Pasquale G, Maier W, Dirsch O, De Groot P, Wu YP, Noll G, Leskosek B, Meier B, Hess OM; Working Group on Novel Surface Coating of Biomedical Devices (SCOL). Stent coating with titanium-nitride-oxide for reduction of neointimal hyperplasia. Circulation. 2001 Aug 21;104(8):928-33.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pilgrim T, Räber L, Limacher A, Wenaweser P, Cook S, Stauffer JC, Garachemani A, Moschovitis A, Meier B, Jüni P, Windecker S. Five-year results of a randomised comparison of titanium-nitride-oxide-coated stents with zotarolimus-eluting stents for coronary revascularisation. EuroIntervention. 2015 Mar;10(11):1284-7. doi: 10.4244/EIJY15M01_04.


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:


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

ClinicalTrials.gov processed this record on September 26, 2016