Aortix Therapy for Perioperative Reduction of Kidney Injury

NCT ID: NCT04999163

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-17
• Study Completion Date: 2023-08-22

Brief 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.

Detailed 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 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.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Aortix Arm

Subject receives the Aortix device.

Group Type: EXPERIMENTAL

Aortix System

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 Type: DEVICE

Eligibility Criteria

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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• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Procyrion Australia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Procyrion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Adelaide Hospital

Adelaide, , Australia

Prince Charles Hospital

Brisbane, , Australia

Princess Alexandra Hospital

Brisbane, , Australia

Monash Health

Melbourne, , Australia

Macquarie University

Sydney, , Australia

Countries

Australia

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

PVP054

Identifier Type: -

Identifier Source: org_study_id