Aortix Therapy for Perioperative Reduction of Kidney Injury (A Priori)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Device: Aortix System

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beth Neely; Phone Number: 832-536-1601; Email: Beth@procyrion.com
• Study Contact Backup: Name: Rubi Reyes-Fuentez; Phone Number: 832-536-1601; Email: rubi@procyrion.com

Study Locations

• Australia
  • Adelaide, Australia
    • Royal Adelaide Hospital
  • Brisbane, Australia
    • Princess Alexandra Hospital
  • Brisbane, Australia
    • Prince Charles Hospital
  • Melbourne, Australia
    • Monash Health
  • Sydney, Australia
    • Macquarie University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

   -

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Procyrion
• Collaborators: Procyrion Australia Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: PVP054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes