Trial Outcomes & Findings for Aortix Therapy for Perioperative Reduction of Kidney Injury (NCT NCT04999163)

NCT ID: NCT04999163

Last Updated: 2024-11-12

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Enrollment to 30 days post-surgery
• Results posted on: 2024-11-12

Participant Flow

Patients were enrolled at 4 investigational sites in Australia between July 17, 2022 and August 7, 2023.

Participant milestones

Measure	Aortix Arm Patients who meet all inclusion and none of the exclusion criteria for the study and agree to receive the Aortix system implant are followed in the Aortix Arm.	Non-Aortix Arm Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant are followed in the non-Aortix arm.
Overall Study STARTED	11	9
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Aortix Arm Patients who meet all inclusion and none of the exclusion criteria for the study and agree to receive the Aortix system implant are followed in the Aortix Arm.	Non-Aortix Arm Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant are followed in the non-Aortix arm.
Overall Study Surgery completed at hospital not participating in the study.	1	0
Overall Study Study enrollment stopped prior to implant.	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Aortix Therapy for Perioperative Reduction of Kidney Injury

Baseline characteristics by cohort

Measure	Aortix Arm n=8 Participants Patients who meet all inclusion and none of the exclusion criteria for the study and agree to receive the Aortix system implant are followed in the Aortix Arm.	Non-Aortix Arm n=9 Participants Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant are followed in the non-Aortix arm.	Total n=17 Participants Total of all reporting groups
Age, Continuous	66.0 years STANDARD_DEVIATION 8.67 • n=5 Participants	71.4 years STANDARD_DEVIATION 6.98 • n=7 Participants	68.9 years STANDARD_DEVIATION 8.07 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
AKI Stage AKI Stage 1	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
AKI Stage AKI Stage 2	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
AKI Stage AKI Stage 3	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
AKI Stage None	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
eGFR	49.9 ml/min/1.73m^2 STANDARD_DEVIATION 8.32 • n=5 Participants	46.6 ml/min/1.73m^2 STANDARD_DEVIATION 10.82 • n=7 Participants	48.1 ml/min/1.73m^2 STANDARD_DEVIATION 9.58 • n=5 Participants
NYHA Classification Class I	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
NYHA Classification Class II	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
NYHA Classification Class III	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
NYHA Classification Class IV	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
LVEF	47.0 percentage of LV ejection fraction STANDARD_DEVIATION 16.46 • n=5 Participants	56.8 percentage of LV ejection fraction STANDARD_DEVIATION 13.24 • n=7 Participants	52.2 percentage of LV ejection fraction STANDARD_DEVIATION 15.21 • n=5 Participants
Height	172.6 cm STANDARD_DEVIATION 8.92 • n=5 Participants	172.9 cm STANDARD_DEVIATION 9.37 • n=7 Participants	172.7 cm STANDARD_DEVIATION 8.87 • n=5 Participants
Weight	101.4 kg STANDARD_DEVIATION 19.74 • n=5 Participants	76.0 kg STANDARD_DEVIATION 13.31 • n=7 Participants	88.0 kg STANDARD_DEVIATION 20.71 • n=5 Participants
BMI	32.2 kg/m^2 STANDARD_DEVIATION 7.04 • n=5 Participants	25.4 kg/m^2 STANDARD_DEVIATION 4.05 • n=7 Participants	29.1 kg/m^2 STANDARD_DEVIATION 6.71 • n=5 Participants

PRIMARY outcome

Timeframe: Enrollment to 30 days post-surgery

Population: All participants that had an attempted or successful Aortix device implant.

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

Outcome measures

Measure	Aortix Arm n=8 Participants Participants who meet all the inclusion and none of the exclusion criteria and agree to receive the Aortix device implant.	Non-Aortix Arm Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant are followed in the non-Aortix arm.
Number of Participants With Serious Adverse Events Related to Aortix Hemolysis, Transient, Major	1 Participants	—
Number of Participants With Serious Adverse Events Related to Aortix Bleeding (BARC 3b)	1 Participants	—
Number of Participants With Serious Adverse Events Related to Aortix No Serious Related Adverse Events	6 Participants	—

PRIMARY outcome

Timeframe: Baseline to 72 hours post-surgery

Population: All participants who completed follow up in the study. 1 participant in the Aortix arm was excluded from analysis due to significant change in medical status.

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.

Outcome measures

Measure	Aortix Arm n=7 Participants Participants who meet all the inclusion and none of the exclusion criteria and agree to receive the Aortix device implant.	Non-Aortix Arm n=9 Participants Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant are followed in the non-Aortix arm.
Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery From None to AKI Stage 2	1 Participants	0 Participants
Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery From None to AKI Stage 3	1 Participants	0 Participants
Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery From AKI Stage 1 to None	0 Participants	1 Participants
Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery Missing Data	0 Participants	1 Participants
Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery No Change	1 Participants	7 Participants
Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery From None to AKI Stage 1	4 Participants	0 Participants

PRIMARY outcome

Timeframe: Aortix placement to 30 days post- surgery

Population: All participants who completed the study are included in this analysis. One patient in the Aortix Arm was excluded due to significant change in medical status.

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.

Outcome measures

Measure	Aortix Arm n=7 Participants Participants who meet all the inclusion and none of the exclusion criteria and agree to receive the Aortix device implant.	Non-Aortix Arm n=9 Participants Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant are followed in the non-Aortix arm.
Number of Participants Requiring Postoperative Use of Renal Replacement Therapy, Ultrafiltration, and/or Dialysis.	1 Participants	1 Participants

PRIMARY outcome

Timeframe: If discharged by day 30 post-surgery

Population: Participants who completed the study are included in this analysis. One patient in the Aortix Arm is excluded from this analysis due to significant change in medical status.

Characterize the rate of 30-day post-surgery readmission due to worsening renal function

Outcome measures

Measure	Aortix Arm n=7 Participants Participants who meet all the inclusion and none of the exclusion criteria and agree to receive the Aortix device implant.	Non-Aortix Arm n=9 Participants Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant are followed in the non-Aortix arm.
Effectiveness	0 Participants	0 Participants

Adverse Events

Aortix Arm

Serious events: 8 serious events

Other events: 6 other events

Deaths: 0 deaths

Non-Aortix Arm

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aortix Arm n=8 participants at risk Patients who meet all inclusion and none of the exclusion criteria for the study and agree to receive the Aortix system implant are followed in the Aortix Arm.	Non-Aortix Arm n=9 participants at risk Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant are followed in the non-Aortix arm.
Blood and lymphatic system disorders Hemolysis, Transient, Major	12.5% 1/8 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.	0.00% 0/9 • Adverse Events were collected from enrollment to 30-Days post surgery.
Vascular disorders Bleeding	50.0% 4/8 • Number of events 4 • Adverse Events were collected from enrollment to 30-Days post surgery.	22.2% 2/9 • Number of events 2 • Adverse Events were collected from enrollment to 30-Days post surgery.
Renal and urinary disorders Renal Injury	25.0% 2/8 • Number of events 2 • Adverse Events were collected from enrollment to 30-Days post surgery.	11.1% 1/9 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.
Cardiac disorders Cardiogenic Shock	12.5% 1/8 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.	11.1% 1/9 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.
Cardiac disorders Pericardial Effusion	0.00% 0/8 • Adverse Events were collected from enrollment to 30-Days post surgery.	11.1% 1/9 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.
Vascular disorders Vascular Injury	0.00% 0/8 • Adverse Events were collected from enrollment to 30-Days post surgery.	11.1% 1/9 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.
Psychiatric disorders Psychiatric Episode	12.5% 1/8 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.	0.00% 0/9 • Adverse Events were collected from enrollment to 30-Days post surgery.
Blood and lymphatic system disorders Anemia	12.5% 1/8 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.	0.00% 0/9 • Adverse Events were collected from enrollment to 30-Days post surgery.
Cardiac disorders Hypotension	12.5% 1/8 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.	0.00% 0/9 • Adverse Events were collected from enrollment to 30-Days post surgery.
Gastrointestinal disorders Gyn/GU Miscellaneous	0.00% 0/8 • Adverse Events were collected from enrollment to 30-Days post surgery.	11.1% 1/9 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.
General disorders Other	25.0% 2/8 • Number of events 3 • Adverse Events were collected from enrollment to 30-Days post surgery.	11.1% 1/9 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/8 • Adverse Events were collected from enrollment to 30-Days post surgery.	11.1% 1/9 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.

Other adverse events

Measure	Aortix Arm n=8 participants at risk Patients who meet all inclusion and none of the exclusion criteria for the study and agree to receive the Aortix system implant are followed in the Aortix Arm.	Non-Aortix Arm n=9 participants at risk Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant are followed in the non-Aortix arm.
Renal and urinary disorders Renal Injury	37.5% 3/8 • Number of events 3 • Adverse Events were collected from enrollment to 30-Days post surgery.	11.1% 1/9 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.
Cardiac disorders Arrhythmia	0.00% 0/8 • Adverse Events were collected from enrollment to 30-Days post surgery.	11.1% 1/9 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.
Vascular disorders Bleeding Event	12.5% 1/8 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.	0.00% 0/9 • Adverse Events were collected from enrollment to 30-Days post surgery.
Gastrointestinal disorders GI Miscellaneous	0.00% 0/8 • Adverse Events were collected from enrollment to 30-Days post surgery.	11.1% 1/9 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	12.5% 1/8 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.	11.1% 1/9 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.
General disorders Other	12.5% 1/8 • Number of events 1 • Adverse Events were collected from enrollment to 30-Days post surgery.	0.00% 0/9 • Adverse Events were collected from enrollment to 30-Days post surgery.

Additional Information

Sr. Director, Clinical Affairs

Procyrion, Inc.

Phone: 650-208-1118

Email: tami@procyrion.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place