Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000135314
Ethics application status
Approved
Date submitted
10/03/2008
Date registered
14/03/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Multi-Center Feasibility Study Evaluating the Osprey Medical Contrast (dye injected into coronary blood vessels) Removal System during diagnostic or interventional percutaneous coronary procedure - in order to prevent contrast induced nephropathy.
Scientific title
A Multi-Center Feasibility Study Evaluating the Osprey Medical Contrast Removal System in participants with renal deficiency
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contrast-induced nephropathy 2923 0
Condition category
Condition code
Renal and Urogenital 3059 3059 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Contrast retrieval after diagnostic or interventional coronary procedure (e.g. angiogram), 30 day follow-up post procedure, evaluation the safety of the Osprey Medical Contrast System used to retrieve contrast (dye) from the coronary sinus before the dye can damage the kidneys. The device is used for a few seconds after a patient is injected with contrast
Intervention code [1] 2650 0
Prevention
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3940 0
To describe the safety of the Osprey Medical Contrast Removal System by summarising all system and procedure-related adverse events and estimating the serious - and procedure related serious adverse even-free rate through 30-days post treatment. System and procedure related events include death, myocardial infarction, arrhythmias, pericardial hemorrhage/tamponade requiring treatment, coronary sinus perforation, dissection, or occlusion, blood loss requiring transfusion, other events related to partial coronary sinus occlusion and suction. System and procedure-related events are those events that are rated as probably related or related utilizing the protocol-specified adverse event rating system and adjudication process
Timepoint [1] 3940 0
30 days post diagnostic or interventional coronary contrast procedure
Secondary outcome [1] 6622 0
To determine ease of use, utilizing the Likert rating (1-5), of the Osprey Medical Contrast-Induced Nephropathy System.
Timepoint [1] 6622 0
Day 1 (procedure day)
Secondary outcome [2] 7090 0
To estimate the rate of Adverse Events (AE) for the study group.
Timepoint [2] 7090 0
30 days post diagnostic or interventional coronary contrast procedure
Secondary outcome [3] 7091 0
Contrast media removal sub-study will be conducted at a central laboratory utilizing Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES). This analysis method utilizes inductively coupled plasma to produce excited atoms and ions that emit electromagnetic radiation at wavelengths characteristic of a particular element. In this case, the element of interest is iodine, which will be used to calculate the percent removal of contrast media during the activation episodes.
Timepoint [3] 7091 0
30 days post diagnostic or interventional coronary contrast procedure
Secondary outcome [4] 8552 0
To summarize the change in serum creatinine and eGFR pre-procedure and 72 hours post procedure and to provide an estimate of the number of subjects that develop CIN.
Timepoint [4] 8552 0
Day of procedure and day 3 post procedure
Secondary outcome [5] 8553 0
To summarize the rate of successful coronary sinus cannulations with the study device. A cannulation is considered successful if the study device is deployed into the coronary sinus.
Timepoint [5] 8553 0
Day of procedure

Eligibility
Key inclusion criteria
The subject is at least 18 years of age, is a candidate for diagnostic or interventional percutaneous coronary procedure utilizing contrast has documented CKD and an estimated GFR is <60 and > 15 ml/min/1.73 m2 , the subject (or subject’s legal representative) is willing and able to provide appropriate informed consent, the subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subject is know to be or suspected to be pregnant, has a life expectancy of less than twelve (12) months, is allergic to contrast media nickel and/or titanium, has a known bleeding disorder (e.g., bleeding -including thrombocytopenia [< 100,000 platelet count], heparin-induced thrombocytopenia, hemophilia, or von Willebrand disease), is unavailable for follow-up, has undergone percutaneous diagnostic or therapeutic procedure within 72 hours of the proposed contrast removal procedure, is currently participating in another investigational device or drug study, has a pacemaker lead or other device placed within the coronary sinus, has had a percutaneous mitral annuloplasty with the device placed in the coronary sinus, has diagnosis of NYHA Class IV heart failure or has had recent exacerbation of heart failure requiring hospitalization within last four weeks or baseline BNP of 900 or greater, has had an acute myocardial infarction within the last 72 hours, INR > 1.8 within one (1) week of the procedure, has an active infection within the last month and/or WBC is > 10.0, has a Hb < 10.0 within one (1) week of the procedure, is not an appropriate candidate for catheterization of the coronary arteries or coronary sinus, unstable clinical situation precluding placement or operation of the Osprey Medical Contrast Removal System coronary sinus catheter, the Principal Investigator determines the subject is not an appropriate candidate for the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 603 0
3004
Recruitment outside Australia
Country [1] 818 0
Germany
State/province [1] 818 0
Freiburg

Funding & Sponsors
Funding source category [1] 3172 0
Commercial sector/Industry
Name [1] 3172 0
Osprey Medical Pty Ltd
Country [1] 3172 0
Australia
Funding source category [2] 3173 0
Government body
Name [2] 3173 0
AUSIndustry
Country [2] 3173 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Osprey Medical Pty Ltd
Address
Level 4
167 Eagle Street
Brisbane QLD 4000
Country
Australia
Secondary sponsor category [1] 2844 0
None
Name [1] 2844 0
Address [1] 2844 0
Country [1] 2844 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5153 0
The Alfred Research and Ethics Committee
Ethics committee address [1] 5153 0
The Alfred Hospital
Commercial Road
Melbourne Victoria 3004
Ethics committee country [1] 5153 0
Date submitted for ethics approval [1] 5153 0
Approval date [1] 5153 0
12/02/2008
Ethics approval number [1] 5153 0
274/07

Summary
Brief summary
The purpose of this clinical study is to assess the safety and ease of use of the Osprey Medical Contrast Induced Nephropathy System in contrast retrieval during/after diagnostic or interventional percutaneous coronary procedure
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28433 0
Address 28433 0
Country 28433 0
Phone 28433 0
Fax 28433 0
Email 28433 0
Contact person for public queries
Name 11590 0
Ed Shapland
Address 11590 0
c/o CM Capital Investment
Level 4
167 Eagle Street
Brisbane QLD 4000
Country 11590 0
Australia
Phone 11590 0
+61 7 32215922
Fax 11590 0
+61 7 32215933
Email 11590 0
[email protected]
Contact person for scientific queries
Name 2518 0
Terry Pertile
Address 2518 0
c/o CM Capital Investment
Level 4
167 Eagle Street
Brisbane QLD 4000
Country 2518 0
Australia
Phone 2518 0
+61 7 32215922
Fax 2518 0
+61 7 32215933
Email 2518 0
[email protected]

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.