Aortix Therapy for Perioperative Reduction of Kidney Injury

Acute Kidney Injury Clinical Trial

— A Priori  

Official title:

Aortix Therapy for Perioperative Reduction of Kidney Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04999163
• Other study ID #: PVP054
• Status: Completed
• Phase: N/A
• Start date: June 5, 2022
• Est. completion date: August 22, 2023

Study information

• Verified date: November 2023
• Source: Procyrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a prospective, non-randomized feasibility study to evaluate the safety and performance of providing support with the Aortix System to patients at heightened risk of acute kidney injury (AKI) undergoing cardiovascular surgery.

Description:

The study is a prospective, non-randomized feasibility study to evaluate the safety and performance of providing support with the Aortix System to patients at heightened risk of acute kidney injury (AKI) undergoing cardiovascular surgery. Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant will be followed in a the non-Aortix arm. Both arms will have the same visit schedule and data collection requirements with the exception of data pertaining to the Aortix system. Data will be reported for both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 22, 2023
• Est. primary completion date: August 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

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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

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Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Prince Charles Hospital	Brisbane
Australia	Princess Alexandra Hospital	Brisbane
Australia	Monash Health	Melbourne
Australia	Macquarie University	Sydney

Sponsors (2)

Lead Sponsor	Collaborator
Procyrion	Procyrion Australia Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Report the rate of Occurrence of Serious Adverse Events related to the Aortix therapy	Enrollment to 30 days post-surgery
Primary	Effectiveness	Characterize the incidence of AKI observed up to 72 hours post-surgery using the KDIGO criteria	baseline to 72 hours post-surgery
Primary	Effectiveness	Characterize the rate of postoperative use of renal replacement therapy (RRT), ultrafiltration and/or dialysis	Aortix placement to 30 days post- surgery
Primary	Effectiveness	Characterize the rate of 30-day post-surgery readmission due to worsening renal function	If discharged by day 30 post-surgery