Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000196347
Ethics application status
Approved
Date submitted
10/04/2008
Date registered
14/04/2008
Date last updated
11/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomized, Multi-Center, Single-Blind Comparison of the Conor Cobalt Chromium Reservoir Based Stent with Sirolimus-Elution versus the TAXUS Liberte Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Scientific title
A Multi-Center, Randomized Evaluation of Treatment Outcomes in Patients with De Novo Coronary Atherosclerotic Lesions Treated with the Conor Sirolimus-eluting Coronary Stent System compared to the TAXUS Liberte Paclitaxel-eluting Coronary System Assessed by Angiographic Late Loss at Six Months
Secondary ID [1] 539 0
Clinical Trials.gov NCT 00606333
Universal Trial Number (UTN)
Trial acronym
The RES-ELUTION Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Atherosclerosis 3028 0
Condition category
Condition code
Cardiovascular 3181 3181 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Percutaneous coronary intervention for treatment of a single coronary lesion with implantation of a Conor Sirolimus-eluting Coronary Stent. The coronary stenting procedure can take from one to two hours while the stent is a permanent implant.
Intervention code [1] 2774 0
Treatment: Devices
Comparator / control treatment
Percutaneous coronary intervention for treatment of a single coronary lesion with implantation of a TAXUS Liberte Paclitaxel-eluting Coronary Stent System. The coronary stenting procedure can take from one to two hours, but the stent is a permanent implant.
Control group
Active

Outcomes
Primary outcome [1] 4069 0
Angiographic in-stent late loss as measured by Quantitative Coronary Angiography.
Timepoint [1] 4069 0
6 months post procedure
Secondary outcome [1] 6844 0
Target Lesion Failure
Timepoint [1] 6844 0
Hospital discharge, 30 days, 6 months and annually through 5 years.
Secondary outcome [2] 6845 0
Target Vessel Failure
Timepoint [2] 6845 0
Hospital discharge, 30 days, 6 months and annually through 5 years
Secondary outcome [3] 6846 0
Major adverse cardiac events
Timepoint [3] 6846 0
Hospital discharge, 30 days, 6 months and annually through 5 years
Secondary outcome [4] 6847 0
Incidence of stent thrombosis
Timepoint [4] 6847 0
Hospital discharge, 30 days, 6 months and annually through 5 years
Secondary outcome [5] 6848 0
Percent volume obstruction of the stent by intravascular ultrasound
Timepoint [5] 6848 0
6 months

Eligibility
Key inclusion criteria
The subject is eligible for percutaneous coronary intervention and coronary artery bypass graft surgery,
The subject has a diagnosis of stable or unstable angina, or silent ischemia,
The subject has a left ventricular ejection fraction >30%,
The subject requires treatment of a single de novo lesion in a native coronary artery,
The subject understands the study requriements, is willing to comply with all study procedures and has provided written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The subject has undergone prior coronary artery bypass graft surgery, prior coronary brachytherapy, prior coronary stent implant to the target vessel, prior coronary intervention within 30 days, or prior revascularization to the target vessel within the previous 6 months.
The subject has experienced recent myocardial infarction within 72 hours.
The subject has experienced a cerebrovascular accident within the last 6 months, active gastrointestinal bleeding within the last 3 months, has a known bleeding disorder, hypercoagulable disorder or thrombocytopenia.
The subject is a female of childbearing potential with a positive pregnancy test or is lactating.
The subject has co-morbidities that could interfere with completion of study procedures, or life expectancy less than 24 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All potential participants will be screened for general eligibility criteria following informed consent. Screening procedures will include baseline coronary angiography to assess if the target lesion and vessel meet eligibility criteria. Randomization will be handled either via phone call or web access to a central automated randomization service using which will provide treatment assignment. Investigators treating enrolled subjects will not be blinded to treatment assignment to ensure safe and proper use of both the control and investigational device. The subject will be blinded to treatment assignment unless for unforseen reasons, in the interest of the subject's safety, it is determined that unblinding is required to protect the individual.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted using a centralized randomization service. Randomization will be done on a 1:1 basis within each site. The randomization schedule was constructed using a random permuted block scheme stratified by site and diabetic status within the site randomization block.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
21/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
388
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 820 0
3168
Recruitment postcode(s) [2] 821 0
3065
Recruitment postcode(s) [3] 822 0
5000
Recruitment outside Australia
Country [1] 886 0
Belgium
State/province [1] 886 0
Antwerpen
Country [2] 887 0
Belgium
State/province [2] 887 0
Genk
Country [3] 888 0
Belgium
State/province [3] 888 0
Leuven
Country [4] 889 0
Belgium
State/province [4] 889 0
Liege
Country [5] 890 0
Belgium
State/province [5] 890 0
Aalst
Country [6] 891 0
France
State/province [6] 891 0
Paris
Country [7] 892 0
France
State/province [7] 892 0
Ollioules
Country [8] 893 0
France
State/province [8] 893 0
Toulouse
Country [9] 894 0
France
State/province [9] 894 0
Creteil
Country [10] 895 0
Germany
State/province [10] 895 0
Hamburg
Country [11] 896 0
Germany
State/province [11] 896 0
Aachen
Country [12] 897 0
Germany
State/province [12] 897 0
Villingen
Country [13] 898 0
Germany
State/province [13] 898 0
Bad Krozingen
Country [14] 899 0
Germany
State/province [14] 899 0
Bad Segeberg
Country [15] 900 0
Germany
State/province [15] 900 0
Berlin
Country [16] 901 0
Netherlands
State/province [16] 901 0
Breda
Country [17] 902 0
Netherlands
State/province [17] 902 0
Eindhoven
Country [18] 903 0
Netherlands
State/province [18] 903 0
Nieuwegein
Country [19] 904 0
New Zealand
State/province [19] 904 0
Auckland
Country [20] 905 0
New Zealand
State/province [20] 905 0
Christchurch
Country [21] 906 0
United Kingdom
State/province [21] 906 0
London
Country [22] 907 0
United Kingdom
State/province [22] 907 0
Southampton
Country [23] 908 0
United Kingdom
State/province [23] 908 0
Oxford
Country [24] 909 0
United Kingdom
State/province [24] 909 0
Leeds
Country [25] 910 0
United Kingdom
State/province [25] 910 0
Brighton
Country [26] 911 0
United Kingdom
State/province [26] 911 0
Scotland

Funding & Sponsors
Funding source category [1] 3284 0
Commercial sector/Industry
Name [1] 3284 0
Conor Medsystems, LLC
Country [1] 3284 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Conor Medsystems, LLC
Address
1003 Hamilton Court
Menlo Park
California 94025
Country
United States of America
Secondary sponsor category [1] 2939 0
None
Name [1] 2939 0
Address [1] 2939 0
Country [1] 2939 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28515 0
Address 28515 0
Country 28515 0
Phone 28515 0
Fax 28515 0
Email 28515 0
Contact person for public queries
Name 11672 0
Sidney A. Cohen, MD, PhD, Vice President of Clinical Research Conor Medsystems & Cordis Corporation
Address 11672 0
Conor Medsystems
1003 Hamilton Court
Menlo Park, CA 94025
Country 11672 0
United States of America
Phone 11672 0
+1. 650.614.2726
Fax 11672 0
+1.650.614.4141
Email 11672 0
[email protected]
Contact person for scientific queries
Name 2600 0
Sidney A. Cohen, MD, PhD, Vice President of Clinical Research Conor Medsystems & Cordis Corporation
Address 2600 0
Conor Medsystems
1003 Hamilton Court
Menlo Park, CA 94025
Country 2600 0
United States of America
Phone 2600 0
1 650.614.2726
Fax 2600 0
Email 2600 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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