NCT04999163

Aortix Therapy for Perioperative Reduction of Kidney Injury

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Procyrion · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-17
• Primary completion: 2023-08-22
• Completion: 2023-08-22
• First posted: 2021-08-10
• Last updated: 2024-11-12
• Results posted: 2024-11-12

Locations

5 sites across 1 country: Australia

Regulatory

• FDA-regulated device study