NCT00492908

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 1, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

June 25, 2007

Last Update Submit

April 30, 2014

Conditions

Coronary Heart Disease

Keywords

Coronary RevascularizationTitanium-Nitride-Oxide Coated StentZotarolimus-Eluting Stent

Outcome Measures

Primary Outcomes (1)

  • In-stent late luminal loss

    6-8 months after stent implantation

Secondary Outcomes (1)

  • TLR, TVR, Death or MI, CV death or MI, CV death, Death, MI, Stent thrombosis, Stenosis, Restenosis

    30 days, 6-8 months, 1, 2, 3, 4 and 5 years

Study Arms (2)

Titanium Nitride Oxide Coated Stent

ACTIVE COMPARATOR

Stent

Device: Helistent Titan2 (Titanium coated stent)

Zotarohlimus Eluting Stent

ACTIVE COMPARATOR

Stent

Device: EndeavorTM (Zotarolimus-Eluting Stent)

Interventions

Helistent Titan2 (Titanium coated stent)DEVICE

Titan2

Titanium Nitride Oxide Coated Stent
EndeavorTM (Zotarolimus-Eluting Stent)DEVICE

Endeavor

Zotarohlimus Eluting Stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (4)

  • Windecker S, Simon R, Lins M, Klauss V, Eberli FR, Roffi M, Pedrazzini G, Moccetti T, Wenaweser P, Togni M, Tuller 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. doi: 10.1161/CIRCULATIONAHA.104.486647. Epub 2005 May 9.

    PMID: 15883209BACKGROUND

  • 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. doi: 10.1161/hc3401.093146.

    PMID: 11514381BACKGROUND

  • Pilgrim T, Raber L, Limacher A, Wenaweser P, Cook S, Stauffer JC, Garachemani A, Moschovitis A, Meier B, Juni 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.

    PMID: 25572026DERIVED

  • Pilgrim T, Raber L, Limacher A, Loffel L, Wenaweser P, Cook S, Stauffer JC, Togni M, Vogel R, Garachemani A, Moschovitis A, Khattab AA, Seiler C, Meier B, Juni P, Windecker S. Comparison of titanium-nitride-oxide-coated stents with zotarolimus-eluting stents for coronary revascularization a randomized controlled trial. JACC Cardiovasc Interv. 2011 Jun;4(6):672-82. doi: 10.1016/j.jcin.2011.02.017.

    PMID: 21700254DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Stephan Windecker, MD

    Department of Cardiology, University Hospital Bern, Bern, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2007

First Posted

June 27, 2007

Study Start

June 1, 2007

Primary Completion

March 1, 2009

Study Completion

August 1, 2013

Last Updated

May 1, 2014

Record last verified: 2014-04

Locations

CH(1)