Aortix Therapy for Perioperative Reduction of Kidney Injury

NCT04999163 | Terminated Results FDA Device

• 1 other identifier: PVP054
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Serious Adverse Events Related to Aortix

  The number of participants with Serious Adverse Events related to the Aortix implant, retrieval, and therapy.

  Enrollment to 30 days post-surgery

• Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery

  The intention is to characterize the change in severity of acute kidney injury observed at 72 hours post-surgery using the KDIGO AKI staging criteria. AKI Stage as defined by the Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guidelines defines the level of acute kidney injury with Stage 1 being the lowest level of kidney injury and Stage 3 being the most severe. None refers to no acute kidney injury.

  Baseline to 72 hours post-surgery

• Number of Participants Requiring Postoperative Use of Renal Replacement Therapy, Ultrafiltration, and/or Dialysis.

  Renal replacement therapy (RRT), ultrafiltration, and dialysis are three treatment options for subjects with severe acute kidney injury and serve as a measure of the degree of acute kidney injury experienced by each group. Any subject receiving any of these therapies prior to 30 days post surgery are counted in this analysis.

  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

Study Arms (2)

Aortix Arm

EXPERIMENTAL

Subject receives the Aortix device.

Device: Aortix System

Non-Aortix Arm

NO INTERVENTION

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.

Interventions

Aortix System 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.

Aortix Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have the following risk factor(s) for AKI prior to surgery:
• Estimated glomerular filtration rate (eGFR) of ≥ 15 and \< 30 ml/min/1.73m2, OR
• eGFR ≥ 30 and \< 60 ml/min/1.73m2 and ONE or more of the following:
• Diabetes (regardless of cause) with metabolic, renal, ophthalmic, neurologic, circulatory, or other complications
• Documented NYHA class III or IV heart failure within 1 year prior to enrollment
• Left ventricular ejection fraction \< 35%
• Hypertension with comorbid heart or kidney disease
• Persistent Atrial Fibrillation
• Planned (non-emergency) cardiac surgical procedure including, but not limited to coronary bypass surgery, surgical valve replacement or valve repair
• Age \>21 years, willing and able to provide written informed consent.

You may not qualify if:

• An eGFR of \<15 ml/min/1.73m2 at enrollment
• Cardiac surgical procedure that uses femoral artery cannulation for cardiopulmonary bypass
• Current support with a durable LVAD, intra-aortic balloon pump, extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g., Impella or TandemHeart)
• Patient has known hypo- or hyper-coagulable state such as disseminated intravascular coagulation or heparin induced thrombocytopenia (HIT)
• Endovascular procedure with ilio-femoral access \>12F within previous 30 days
• Severe Bleeding Risk (any of the following):
• Previous intracranial bleed such that the patient cannot safely use anticoagulation per the study requirements
• Platelet count \<75,000 cells/mm3
• Uncorrectable bleeding diathesis or coagulopathy (e.g., INR ≥ 2 not due to anticoagulation therapy
• Current endovascular stent graft in the descending aorta or either ilio-femoral vessels
• Contraindicated Anatomy:
• Descending aortic anatomy that would prevent safe placement of the device \[\<18 mm or \>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\]
• Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath
• 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)
• Known connective tissue disorder (e.g., Marfan Syndrome) or other aortopathy at risk of vascular injury

Sponsors & Collaborators

• Procyrion: lead
• Procyrion Australia Pty Ltd: collaborator

Study Sites (5)

Royal Adelaide Hospital

Adelaide, Australia

Location

Prince Charles Hospital

Brisbane, Australia

Location

Princess Alexandra Hospital

Brisbane, Australia

Location

Monash Health

Melbourne, Australia

Location

Macquarie University

Sydney, Australia

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

Early termination of the study leading to small numbers of subjects analyzed. The non-Aortix group did not show the expected incidence of acute kidney injury during and following surgery and therefore a comparison between the groups could not be made. As a result study enrollment was stopped early and the study was terminated.

Results Point of Contact

• Title: Sr. Director, Clinical Affairs
• Organization: Procyrion, Inc.

tami@procyrion.com

650-208-1118

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 10, 2021
• Study Start: July 17, 2022
• Primary Completion: August 22, 2023
• Study Completion: August 22, 2023
• Last Updated: November 12, 2024
• Results First Posted: November 12, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)