Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000238875
Ethics application status
Approved
Date submitted
22/02/2012
Date registered
24/02/2012
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Date results information initially provided
25/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reduction of contrast induced nephropathy (CIN) in patients requiring a percutaneous coronary intervention procedure and have chronic renal failure.
Scientific title
Multi-centre, single arm study to evaluate performance and safety of the CINCOR contrast media removal system in chronic renal disease patients requiring a percutaneous coronary intervention procedure.
Secondary ID [1] 280002 0
TP-6201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease in patients with chronic kidney disease. 285911 0
Condition category
Condition code
Renal and Urogenital 286101 286101 0 0
Kidney disease
Cardiovascular 286117 286117 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CINCOR contrast removal system removes contrast from the circulatory system before it can reach the kidneys. The system uses a canula inserted into the circulatory system that removes contrast media. The procedure occurs at the same time as the percutaneous coronary procedure.
Intervention code [1] 284326 0
Treatment: Devices
Intervention code [2] 284339 0
Prevention
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286577 0
Device performance, measured by analysing successful use of the system and amount of contrast removed from the participant.
Timepoint [1] 286577 0
Day of surgery.
Secondary outcome [1] 296209 0
Device safety, assessed by analysing adverse events. Adverse events of interest include bleeding, myocardial infarction, dialysis and heart arrhythmias. Adverse events rates will be compared with rates of previous clinical trials conducted on the CINCOR system and rates experienced in percutaneous coronary intervention procedures.
Timepoint [1] 296209 0
24 hours, 4 days and 30 days post percutaneous coronary procedure.

Eligibility
Key inclusion criteria
Chronic renal disease and requires a percutaneous coronary intervention procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not eligable for percutaneous coronary procedure or has an allergy to contrast media, unable/unwilling to provide consent, is pregnant.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are screened for eligibility based on available clinical measurements. If eligible, participants are invited to participate in the study and asked to provide informed consent. All participants are allocated to the study intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
None.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/02/2012
Actual
12/01/2012
Date of last participant enrolment
Anticipated
Actual
12/11/2012
Date of last data collection
Anticipated
Actual
30/12/2012
Sample size
Target
15
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 5025 0
3004
Recruitment outside Australia
Country [1] 4162 0
New Zealand
State/province [1] 4162 0
Auckland

Funding & Sponsors
Funding source category [1] 284763 0
Commercial sector/Industry
Name [1] 284763 0
Osprey Medical Pty Ltd
Country [1] 284763 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Osprey Medical Pty Ltd
Address
c/o CM Capital Investments Pty Ltd
Level 4, 167 Eagle Street
Brisbane, QLD, 4000
Country
Australia
Secondary sponsor category [1] 283653 0
None
Name [1] 283653 0
Address [1] 283653 0
Country [1] 283653 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286758 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 286758 0
The Alfred Hospital
Commercial Road
Prahran, VIC, 3004
Ethics committee country [1] 286758 0
Australia
Date submitted for ethics approval [1] 286758 0
27/10/2011
Approval date [1] 286758 0
12/01/2012
Ethics approval number [1] 286758 0
1/11/0371

Summary
Brief summary
The purpose of the study is to help reduce the incidence of contrast induced nephropathy in patients who have impaired kidney function and required a purcutaneous coronary intervention procedure (e.g. stent) due to cardiovascular disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33818 0
Prof Stephen Duffy
Address 33818 0
Alfred Hospital, 55 Commercial Road, Melbourne, Victoria, 3004
Country 33818 0
Australia
Phone 33818 0
+61390762000
Fax 33818 0
Email 33818 0
h.centre@alfred.org
Contact person for public queries
Name 17065 0
Mr Dan Mans
Address 17065 0
7600 Executive Drive
Eden Praire, MN, 55344
Country 17065 0
United States of America
Phone 17065 0
+1 952 955 8236
Fax 17065 0
+1 952 955 8171
Email 17065 0
dmans@ospreymed.com
Contact person for scientific queries
Name 7993 0
Mr Dan Mans
Address 7993 0
7600 Executive Drive
Eden Praire, MN, 55344
Country 7993 0
United States of America
Phone 7993 0
+1 952 955 8236
Fax 7993 0
+1 952 955 8171
Email 7993 0
dmans@ospreymed.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study closed


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.