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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04999163




Registration number
NCT04999163
Ethics application status
Date submitted
3/08/2021
Date registered
10/08/2021

Titles & IDs
Public title
Aortix Therapy for Perioperative Reduction of Kidney Injury
Scientific title
Aortix Therapy for Perioperative Reduction of Kidney Injury
Secondary ID [1] 0 0
PVP054
Universal Trial Number (UTN)
Trial acronym
A Priori
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Kidney Injury 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Aortix System

Experimental: Aortix Arm - Subject receives the Aortix device.

No intervention: Non-Aortix Arm - Control Arm consists of subjects who choose not to receive the Aortix device or who do not meet the anatomical requirements to receive the Aortix device.


Treatment: Devices: Aortix System
Aortix is indicated as a partial circulatory support device to increase renal perfusion and reduce the incidence of acute kidney injury (AKI) in patients undergoing cardiac surgery who are at heightened risk of developing AKI.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Serious Adverse Events Related to Aortix
Timepoint [1] 0 0
Enrollment to 30 days post-surgery
Primary outcome [2] 0 0
Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery
Timepoint [2] 0 0
Baseline to 72 hours post-surgery
Primary outcome [3] 0 0
Number of Participants Requiring Postoperative Use of Renal Replacement Therapy, Ultrafiltration, and/or Dialysis.
Timepoint [3] 0 0
Aortix placement to 30 days post- surgery
Primary outcome [4] 0 0
Effectiveness
Timepoint [4] 0 0
If discharged by day 30 post-surgery

Eligibility
Key inclusion criteria
1. Have the following risk factor(s) for AKI prior to surgery:

1. Estimated glomerular filtration rate (eGFR) of = 15 and < 30 ml/min/1.73m2, OR
2. eGFR = 30 and < 60 ml/min/1.73m2 and ONE or more of the following:

1. Diabetes (regardless of cause) with metabolic, renal, ophthalmic, neurologic, circulatory, or other complications
2. Documented NYHA class III or IV heart failure within 1 year prior to enrollment
3. Left ventricular ejection fraction < 35%
4. Hypertension with comorbid heart or kidney disease
5. Persistent Atrial Fibrillation
2. Planned (non-emergency) cardiac surgical procedure including, but not limited to coronary bypass surgery, surgical valve replacement or valve repair
3. Age >21 years, willing and able to provide written informed consent.

-
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. An eGFR of <15 ml/min/1.73m2 at enrollment
2. Cardiac surgical procedure that uses femoral artery cannulation for cardiopulmonary bypass
3. Current support with a durable LVAD, intra-aortic balloon pump, extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g., Impella or TandemHeart)
4. Patient has known hypo- or hyper-coagulable state such as disseminated intravascular coagulation or heparin induced thrombocytopenia (HIT)
5. Endovascular procedure with ilio-femoral access >12F within previous 30 days
6. Severe Bleeding Risk (any of the following):

1. Previous intracranial bleed such that the patient cannot safely use anticoagulation per the study requirements
2. Platelet count <75,000 cells/mm3
3. Uncorrectable bleeding diathesis or coagulopathy (e.g., INR = 2 not due to anticoagulation therapy
7. Current endovascular stent graft in the descending aorta or either ilio-femoral vessels
8. Contraindicated Anatomy:

1. Descending aortic anatomy that would prevent safe placement of the device [<18 mm or >31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)]
2. Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath
3. Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g., aneurysm with thrombus; marked tortuosity; significant narrowing or inadequate size of the abdominal aorta, iliac, or femoral arteries; or severe calcification)
4. Known connective tissue disorder (e.g., Marfan Syndrome) or other aortopathy at risk of vascular injury
9. Known hypersensitivity or contraindication to study required medications (e.g., anticoagulation therapy) or device materials (e.g., history of severe reaction to nickel or nitinol)
10. Positive pregnancy test if of childbearing potential
11. Participation in any other clinical investigation that is likely to confound study results or affect 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/08/2023
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Prince Charles Hospital - Brisbane
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Monash Health - Melbourne
Recruitment hospital [5] 0 0
Macquarie University - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Procyrion
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Procyrion Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04999163