Randomized Trial Comparing Titan Stent With Zotarolimus-E... | NCT00492908

Studies
Randomized Trial Comparing Titan Stent With Zotarolimus-Eluting Stent

NCT00492908

Sponsor

University of Bern

Status

Completed

Last Update Posted

May 1, 2014Estimated

Enrollment

303Actual

Phase

Phase 4

Conditions

Coronary Heart Disease

Interventions

Helistent Titan2 (Titanium coated stent)
EndeavorTM (Zotarolimus-Eluting Stent)

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Mar 2009Actual

Completion Date

Aug 2013Actual

First Submitted Date

Jun 25, 2007

First Submission Date that Met QC Criteria

Jun 25, 2007

First Posted Date

Jun 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2014

Last Update Posted Date

May 1, 2014Estimated

Name	Class
Insel Gruppe AG, University Hospital Bern	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

303Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Helistent Titan2 (Titanium coated stent)	Device	Titan2	Titanium Nitride Oxide Coated Stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In-stent late luminal loss		6-8 months after stent implantation

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephan Windecker, MD	Department of Cardiology, University Hospital Bern, Bern, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, University Hospital Bern		Bern		3010	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15883209	Background	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.
11514381

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases