Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000158066
Ethics application status
Approved
Date submitted
16/02/2010
Date registered
18/02/2010
Date last updated
28/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy, feasibility and safety of the CINCOR system for the prevention of Contrast-Induced Nephropathy (CIN) in patients with chronic kidney disease undergoing diagnostic and therapeutic percutaneous coronary interventional (PCI) procedures
Scientific title
Assessment of the retrieval of contrast agent using the CINCOR System in patients with chronic kidney disease undergoing a coronary diagnostic or interventional procedure requiring the use of iodinated contrast media.
Secondary ID [1] 1408 0
Osprey Medical Protocol - TP-6160 / CINCOR Feasibility Trial II
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contrast-Induced Nephropathy in patients with chronic kidney disease and scheduled to undergo a coronary diagnostic or interventional procedure requiring the use of iodinated contrast media 256827 0
Condition category
Condition code
Renal and Urogenital 256974 256974 0 0
Kidney disease
Cardiovascular 256985 256985 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Osprey Medical CINCOR System utilizes catheter system along with institutional vacuum in which contrast media (CM) injected into the left coronary arteries is retrieved from the coronary sinus (CS). The
investigational device works by retrieving contrast agent prior to reaching the systemic circulation and the kidneys thereby helping to avoid the development of contrast induced nephropathy (CIN).
The removal catheter will be in place in the coronary sinus for the duration of the PCI procedure (approximately 1 to 2 hours). Each collection episode will require that the vacuum is activated for approximately 8-12 seconds. It is anticipated that up to 12 collection episodes will occur during a PCI procedure.
Intervention code [1] 256030 0
Prevention
Intervention code [2] 256036 0
Treatment: Devices
Comparator / control treatment
Single arm study, no comparator. All patients will undergo standard of care treatment, peri-procedural hydration, for the prevention of CIN.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257864 0
Retrieval of contrast agent. Success criterion for this endpoint is 40% or greater retrieval of contrast agent. This criterion will be assessed by analyzing collected blood for iodine content by inductively coupled plasma optical emission spectroscopy (ICP-OES)
Timepoint [1] 257864 0
Measured on the day of the coronary procedure.
Secondary outcome [1] 263317 0
To describe the safety of the device by summarising all system- and procedure-related adverse events and estimating the serious system- and procedure-related serious adverse event free rate. Adverse events evaluated include:

Death, Arrhythmia (including ventricular tachycardia and ventricular fibrillation), Myocardial infarction, 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. These events will be evaluated using standard medical techniques including electrocardiogram (ECG), angiography, clinical laboratory tests, and patient interview.
Timepoint [1] 263317 0
Evaluated through 30 days post-procedure. This endpoint will be evaluated at all scheduled and unscheduled study visits. Scheduled post-procedure visits occur at 1, 4, and 30 days post-procedure.

Eligibility
Key inclusion criteria
1. The subject is at least 18 years of age.
2. The subject is a candidate for a diagnostic or therapeutic coronary percutanous coronary interventional (PCI) procedure of the left coronary artery (left main, left anterior descending coronary artery and/or left circumflex artery or branches of these vessels) anticipated to utilize at least 50 mL of iodinated contrast media.
3. The subject has documented chronic kidney disease and an estimated estimated glomerular filtration rate (eGFR) > 15 and < 60 mL/min/1.73m2 [as determined by the Modification of Diet on Renal Disease (MDRD) equation].
4. The subject (or subject’s legal representative) is willing and able to provide appropriate informed consent.
5. 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
1. The subject is currently undergoing renal dialysis.
2. The subject is in acute renal failure or has unstable renal function based on clinical findings and/or a known change in serum creatinine of greater than or equal to 0.5mg/dL or greater than or equal to 25% within 7 days prior to enrolment compared to the last serum creatinine measurement on record.
3. The subject has received contrast media within 7 days prior to the procedure day or a second imaging study of any type which will require iodinated contrast is planned within the 4 days following the protocol-defined procedure.
4. The subject has a known allergy to iodine-based contrast agents that cannot be adequately pre-medicated (patients with a history of true anaphylaxis may not be enrolled).
5. The subject has a known bleeding diathesis (e.g. thrombocytopenia [<100,000 cells/mm3], heparin-induced thrombocytopenia, haemophilia, or von Willebrand disease, any history of intracranial bleeding, or gastrointestinal bleeding gross genitourinary bleeding).
6. The subject is currently on intravenous heparin that cannot be discontinued at least 4 hours before the procedure, intravenous bivalirudin that cannot be discontinued at least 4 hours before the procedure, intravenous abciximab that cannot be discontinued at least 24 hours before the procedure, intravenous tirofiban or eptifibatide that cannot be discontinued at least 6 hours before the procedure, or has received any low molecular weight heparin within 12 hours or factor Xa antagonist (including fondaparinux) within 24 hours of the procedure.
7. The subject is hypotensive (systolic blood pressure < 90 mmHg not corrected by intravenous saline) or requiring intravenous pressors and/or intra-aortic balloon counterpulsation.
8. The subject has decompensated heart failure requiring intravenous diuretic, inotropic, vasopressor or intraaortic balloon support in the previous 7 days.
9. The subject has had recent (within last 72 hours) acute myocardial infarction as defined in the “Universal Definition of Myocardial Infarction”:
a. Detection of rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above the 99th percentile of the upper reference limit and at least one of the following
i. Symptoms of ischemia
ii. Electrocardiogram (ECG) changes indicative of new ischemia (new ST-T changes or new left bundle branch block)
iii. Development of pathological Q waves in the ECG
iv. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
10. The subject requires an intra aortic balloon pump.
11. The subject has an International Normalized Ratio (INR) > 1.8 pre-procedure.
12. The subject has an active bacterial infection within the last month.
13. The subject has haemoglobin (Hb) < 10.0 g/dL within one (1) week of the procedure.
14. The subject is known to be or suspected to be pregnant, or is lactating (all women of child-bearing potential must have a negative pregnancy test within 72 hours before participating in this protocol).
15. The subject has a life expectancy of less than twelve (12) months.
16. The subject has a pacemaker lead, percutaneous mitral annuloplasty or other device placed within the coronary sinus that would limit the ability to successfully cannulated the coronary sinus.
17. The subject has an unstable clinical situation precluding placement or operation of the Osprey Medical CINCOR System.
18. The subject is currently participating in another investigational device or drug study that has not completed its primary endpoint.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2497 0
New Zealand
State/province [1] 2497 0

Funding & Sponsors
Funding source category [1] 256530 0
Commercial sector/Industry
Name [1] 256530 0
Osprey Medical Inc
Country [1] 256530 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Osprey Medical Pty Ltd
Address
Level 4, 167 Eagle Street
Brisbane 4000
Queensland
Country
Australia
Secondary sponsor category [1] 255838 0
None
Name [1] 255838 0
Address [1] 255838 0
Country [1] 255838 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258577 0
The Alfred Ethics Committee
Ethics committee address [1] 258577 0
Ethics committee country [1] 258577 0
Date submitted for ethics approval [1] 258577 0
22/02/2010
Approval date [1] 258577 0
Ethics approval number [1] 258577 0

Summary
Brief summary
The purpose of this clinical study is to evaluate the effectiveness of the procedure for contrast removal as well as describe the safety and device performance of the Osprey Medical CINCOR Contrast Removal System, in patients with chronic kidney disease who are schedule to undergo diagnostic or therapeutic percutaneous coronary interventional procedures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30852 0
Address 30852 0
Country 30852 0
Phone 30852 0
Fax 30852 0
Email 30852 0
Contact person for public queries
Name 14099 0
Suzanne Williams
Address 14099 0
Mobius Medical Pty Ltd
Level 32
1 Market Street
Sydney NSW 2000
Country 14099 0
Australia
Phone 14099 0
+61 2 9275 8838
Fax 14099 0
+61 2 9275 8800
Email 14099 0
suzanne@mobiusmedical.com.au
Contact person for scientific queries
Name 5027 0
Dan Mans
Address 5027 0
7600 Executive Drive, Eden Prairie, MN, 55344
Country 5027 0
United States of America
Phone 5027 0
1-952-955-8236
Fax 5027 0
1-952-955-8171
Email 5027 0
dmans@ospreymed.com

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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