Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000487213
Ethics application status
Approved
Date submitted
30/05/2009
Date registered
18/06/2009
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Antares Coronary Stent System to Facilitate Side Branch Interventions
Scientific title
Treatment sucess with the Antares Stent System for Coronary Artery Stenting at or near a Major Sidebranch
Universal Trial Number (UTN)
Trial acronym
TOP II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 4884 0
Condition category
Condition code
Cardiovascular 237236 237236 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Coronary Stenting involves placing a metal mesh in a blood vessel in the heart to open a blockage. The stent is inserted through a blood vessel in the arm or leg and is put in place by inflating a balloon inside the stent. The stent cannot be removed from the blood vessel once it is in place.
Intervention code [1] 236671 0
Treatment: Devices
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238052 0
Bifurcation Treatment Success- assessed by a visual assessment blood flow and stenosis in both the main vessel and side branch.
Timepoint [1] 238052 0
Measured at the conclusion of the bifurcation procedure
Secondary outcome [1] 242238 0
Major cardiac adverse events including cardiac death, myocardial infarction and Target Lesion Revascularization as determined by clinician observation.
Timepoint [1] 242238 0
Measured at 1 month, 6 months, and 12 months
Secondary outcome [2] 242239 0
Sidebranch Access Success - an evaluation of the ability to access the sidebranch with wire, balloon, and/or stent, to perform sidebranch interventions following Antares stent placement in the main vessel
Timepoint [2] 242239 0
Determined at the conclusion of the bifurcation procedure

Eligibility
Key inclusion criteria
symptomatic or documented myocardial ischemia,
study lesion is a single bifurcation lesion that has not been previously treated,
By angiograpic review the study lesion has a diameter and length appropriate for Antares Stent,
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute myocardial infarction, Shock, Stroke, Coagulopathy, Left main coronary lesion, Total occlusion, Diffuse disease, thrombus or severe calcification, Previous Coronary Artery Bypass Graft (CABG) surgery,

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
None
Date of first participant enrolment
Anticipated
16/06/2009
Actual
15/07/2009
Date of last participant enrolment
Anticipated
Actual
31/08/2009
Date of last data collection
Anticipated
Actual
31/08/2009
Sample size
Target
300
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1805 0
3168
Recruitment outside Australia
Country [1] 1818 0
New Zealand
State/province [1] 1818 0
Auckland
Country [2] 1819 0
Germany
State/province [2] 1819 0
Berlin

Funding & Sponsors
Funding source category [1] 5061 0
Commercial sector/Industry
Name [1] 5061 0
TriReme Medical, Inc.
Country [1] 5061 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
TriReme Medical, Inc.
Address
7060 Koll Center Parkway
Suite 300
Pleasanton, CA 94566
Country
United States of America
Secondary sponsor category [1] 4570 0
Commercial sector/Industry
Name [1] 4570 0
Robust Industries Pty. Ltd
Address [1] 4570 0
95 Stevedore Street Williamstown,
Victoria, 3016
Country [1] 4570 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239164 0
Charite Universitsmedizin Berlin
Ethics committee address [1] 239164 0
Schumannstr 20/21
10098 Berlin
Ethics committee country [1] 239164 0
Germany
Date submitted for ethics approval [1] 239164 0
Approval date [1] 239164 0
14/05/2009
Ethics approval number [1] 239164 0
Ethics committee name [2] 299248 0
Southern Health
Ethics committee address [2] 299248 0
246 Clayon Road, Clayton, Victoria 3168
Ethics committee country [2] 299248 0
Australia
Date submitted for ethics approval [2] 299248 0
16/04/2009
Approval date [2] 299248 0
21/06/2009
Ethics approval number [2] 299248 0
09077B
Ethics committee name [3] 299249 0
NORTHERN X REGIONAL ETHICS COMMITEE
Ethics committee address [3] 299249 0
MINISTRY OF HEALTH
3RD FLOOR, UNISYS BUILDING
650 GREAT SOUTHERN ROAD, PENROSE
AUCKLAND
Ethics committee country [3] 299249 0
New Zealand
Date submitted for ethics approval [3] 299249 0
08/06/2009
Approval date [3] 299249 0
10/07/2009
Ethics approval number [3] 299249 0
NTX/09/05/040

Summary
Brief summary
Study to evalute the use of the Antares Stent System in patients with coronary disease at a location where two vessels are meeting.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 29670 0
Address 29670 0
Country 29670 0
Phone 29670 0
Fax 29670 0
Email 29670 0
Contact person for public queries
Name 12917 0
Erin Tims
Address 12917 0
7060 Koll Center Parkway
Suite 300
Pleasanton, CA 94566
Country 12917 0
United States of America
Phone 12917 0
+1 925-931-1300 ext 212
Fax 12917 0
+1 925-931-1361
Email 12917 0
etims@trirememedical.com
Contact person for scientific queries
Name 3845 0
Erin Tims
Address 3845 0
7060 Koll Center Parkway
Suite 300
Pleasanton, CA 94566
Country 3845 0
United States of America
Phone 3845 0
+1 925-931-1300 ext 212
Fax 3845 0
+1 925-931-1361
Email 3845 0
etims@trirememedical.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.