Clinical trial NCT04999163: Aortix Therapy for Perioperative Reduction of Kidney Injury
Official title: Aortix Therapy for Perioperative Reduction of Kidney Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: Procyrion
Sponsor class: INDUSTRY
Collaborators: name: Procyrion Australia Pty Ltd
First posted: 2021-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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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Primary outcomes:
measure: Number of Participants With Serious Adverse Events Related to Aortix
timeFrame: Enrollment to 30 days post-surgery
measure: Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery
timeFrame: Baseline to 72 hours post-surgery
measure: Number of Participants Requiring Postoperative Use of Renal Replacement Therapy, Ultrafiltration, and/or Dialysis.
timeFrame: Aortix placement to 30 days post- surgery
measure: Effectiveness
timeFrame: If discharged by day 30 post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Brisbane
country: Australia
facility: Prince Charles Hospital
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
city: Melbourne
country: Australia
facility: Monash Health
city: Sydney
country: Australia
facility: Macquarie University
Study officials:
References: