Trial Outcomes & Findings for Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae (NCT NCT04896476)

NCT ID: NCT04896476

Last Updated: 2025-02-18

Results Overview

Composite of new major device related adverse events (MAEs) at 30 days post EchoMark implantation, as adjudicated by the Clinical Events Committee (CEC) including: * Device or procedure-related death * Device related infection * Device related interventions * Device related hospitalizations * Fistula failure * Fistula rupture * Aneurysm

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 30 Days
• Results posted on: 2025-02-18

Participant Flow

Participant milestones

Measure	EchoMark All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	EchoMark All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	2

Baseline Characteristics

Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae

Baseline characteristics by cohort

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Age, Continuous	64.3 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 Days

Composite of new major device related adverse events (MAEs) at 30 days post EchoMark implantation, as adjudicated by the Clinical Events Committee (CEC) including:

• Device or procedure-related death
• Device related infection
• Device related interventions
• Device related hospitalizations
• Fistula failure
• Fistula rupture
• Aneurysm

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Primary Safety Endpoint	0 MAES within 30 days post baseline visit

PRIMARY outcome

Timeframe: 4 Months

Rate of Technical Success defined as the successful implantation of the EchoMark implant. Technical success will be assessed from baseline to 4 months.

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Primary Feasibility Endpoint	20 Participants

PRIMARY outcome

Timeframe: 4 Months

Rate of Technical Success defined as the successful ability to determine blood flow, diameter, and depth measurements using the EchoSure diagnostic ultrasound system. Technical success will be assessed from baseline to 4 months.

Outcome measures

Measure	EchoMark n=273 EchoSure Scans All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Rate of Technical Success Defined as the Successful Ability to Determine Blood Flow, Diameter, and Depth Measurements Using the EchoSure Diagnostic Ultrasound System. Technical Success Will be Assessed From Baseline to 4 Months.	270 EchoSure Scans

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Bland Altman using percentages will assess the agreement between two measurements.

Only duplex images that pass the CoreLab quality control check will be included in the assessment.

The results will be calculated as a percent difference between the two measurements with a value of zero corresponding to exact agreement.

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Comparison of EchoSure and Duplex Measurements Using Percentages	-7.8 Flow Rate Percent Difference Standard Deviation 38.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Bland Altman using percentages will assess the agreement between two measurements.

Only duplex images that pass the CoreLab quality control check will be included in the assessment.

The results will be calculated as a percent difference between the two measurements with a value of zero corresponding to exact agreement.

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Comparison of EchoSure and Duplex Measurements of Diameter	9.4 Diameter Percent Difference Standard Deviation 19.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Bland Altman using percentages will assess the agreement between two measurements.

Only duplex images that pass the CoreLab quality control check will be included in the assessment.

The results will be calculated as a percent difference between the two measurements with a value of zero corresponding to exact agreement.

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Comparison of EchoSure and Duplex Measurements of Depth	18.4 Depth Percent Difference Standard Deviation 23.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 Months

Bland Altman using percentages will assess the agreement between two measurements.

The results will be calculated as a percent difference between the two measurements with a value of zero corresponding to exact agreement.

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Comparison of EchoSure Depth Measurements to Independent Reviewer Measured Depth Results.	18.4 Depth Percent Difference Standard Deviation 23.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: One subject never reached clinical maturation

defined as the number of days from baseline procedure to date of radiographic maturation (date of ultrasound imaging, as adjudicated by the CEC). Radiographic maturation is defined as a fistula with volume flow of 500mL/min and 5mm diameter.

Outcome measures

Measure	EchoMark n=19 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Time to Radiographic Maturation	28.8 Number of Days Standard Deviation 23.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Analysis included subjects with supporting cannulation records

defined as the number of days from baseline procedure to date of clinical maturation. Clinical maturation is defined as 75% of dialysis sessions with successful 2 needle cannulation. Date of clinical maturation is defined as first date of the 4-week window when clinical maturation is achieved.

Outcome measures

Measure	EchoMark n=7 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Time to Clinical Maturation	67.5 Number of Days Standard Deviation 4.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

defined as the percentage of subjects that achieve radiographic maturation (as determined by the physician and adjudicated by the CEC) by end of study. Radiographic maturation is defined as a fistula with 500mL/min and 5mm diameter.

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Radiographic Maturation Success Rate	19 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: 17 subjects were cleared for cannulation and source documents were requested. 2 subjects did not require dialysis treatment. Records were obtained for 7 Subjects.

defined as the percentage of subjects that achieve clinical maturation by end of study. Date of clinical maturation is defined as first date of the 4-week window when clinical maturation is achieved.

Outcome measures

Measure	EchoMark n=7 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Clinical Maturation Success Rate	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Population: Subjects who completed the 6-month visit.

defined by the status (yes/no) of an arteriovenous dialysis access with detectable blood flow through and beyond the anastomosis shown by either an imaging modality or physical examination (presence of a palpable thrill or audible bruit along some point of the arteriovenous dialysis access beyond the arteriovenous anastomosis).

Outcome measures

Measure	EchoMark n=16 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Number of Patients With 6-Month Patency	16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Subjects who completed the 12-month visit

defined by the status (yes/no) of an arteriovenous dialysis access with detectable blood flow through and beyond the anastomosis shown by either an imaging modality or physical examination (presence of a palpable thrill or audible bruit along some point of the arteriovenous dialysis access beyond the arteriovenous anastomosis).

Outcome measures

Measure	EchoMark n=16 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Number of Patients With 12-Month Patency	16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 Days

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Occurrence of Events Occurring Within 30 Days of Implantation That Require Reinterventions (Open or Endovascular), Hospitalizations, or Prolongation of Existing Hospitalization.	1 Events

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Occurrence of Events of Reported Reduction of Blood Flow That Prevents the Ability to Cannulate or Requires Further Assessment and/or Intervention From Baseline Procedure to 12 Months.	4 Events

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Subjects that have been deemed clinically mature

Outcome measures

Measure	EchoMark n=7 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Occurrence of the Reported Inability to Cannulate Fistula Beginning Once the Fistula is Deemed Radiographically and Clinically Mature to 12 Months.	0 Occurrence of Event

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Occurrence of Events of the Development of Steal Syndrome From Baseline to 12 Months.	1 Events

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Occurrence of Events of Bleeding Requiring Surgical Intervention (Including PRBC Transfusion) From Baseline to 12 Months.	0 Events

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Occurrence of Events of Infiltration Requiring Procedural Intervention From Baseline to 12 Months.	2 Events

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Occurrence of Events of Hematoma Requiring Procedural Intervention From Baseline to 12 Months.	0 Events

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 Months

Due to:

1. Migration of the EchoMark device

2. Early resorption of the EchoMark device as defined as breakdown of the EchoMark shape prior to 4 months from index procedure.

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Occurrence of Events of the Inability to Use the EchoSure Component of the System From Baseline to 4 Months	0 Events

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Occurrence of Events of Pain Related to the Study Devices From Baseline to 12 Months	1 Events

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Occurrence of Events of Infection (Not Limited to Infection Requiring Implant Explanation) From Baseline to 12 Months	0 Events

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Occurrence of Events of Infection Confirmed by Either Implant Explanation or Purulent Fluid on Pathologic Assessment During Incision and Drainage Beginning at Baseline to 12 Months	0 Events

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

The proportion of subjects with device success and free from device- and/or procedure related

SAEs (per CEC adjudication) at 12 months including:

• Device or procedure-related death
• Device related infection
• Device related interventions
• Device related hospitalizations
• Fistula failure
• Fistula rupture
• Aneurysm

Outcome measures

Measure	EchoMark n=20 Participants All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Composite of New Major Device Related Adverse Events (MAEs) at 12 Months Post EchoMark LP Implantation, as Adjudicated by the Clinical Events Committee (CEC).	15 Participants

Adverse Events

EchoMark

Serious events: 0 serious events

Other events: 16 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	EchoMark n=20 participants at risk All subjects will undergo a physician exam prior an arteriovenous fistula creation per the institution's standard of care. After the fistula creation is completed, but prior to closure, the EchoMark will be implanted under the outflow vein. EchoMark: The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
Surgical and medical procedures Seroma	0.00% 0/20 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Vascular disorders Fluid Collection	10.0% 2/20 • Number of events 2 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Vascular disorders Stenosis	60.0% 12/20 • Number of events 24 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Surgical and medical procedures Pain (including cannulation-related pain)	20.0% 4/20 • Number of events 4 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Vascular disorders Restenosis	15.0% 3/20 • Number of events 5 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Vascular disorders Reduction in Blood Flow	20.0% 4/20 • Number of events 4 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Surgical and medical procedures Numbness, Tingling	5.0% 1/20 • Number of events 1 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Vascular disorders Steal Syndrome	5.0% 1/20 • Number of events 1 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Injury, poisoning and procedural complications Infiltration	25.0% 5/20 • Number of events 5 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Injury, poisoning and procedural complications Difficulty Cannulating	20.0% 4/20 • Number of events 4 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Vascular disorders Malfunctioning Catheter	5.0% 1/20 • Number of events 1 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Vascular disorders Excessive Bleeding	5.0% 1/20 • Number of events 1 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Vascular disorders In-Stent Restenosis	5.0% 1/20 • Number of events 1 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Vascular disorders Poor Maturation	5.0% 1/20 • Number of events 1 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Vascular disorders Swelling Access Extremity	5.0% 1/20 • Number of events 1 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Vascular disorders Inability to Cannulate	5.0% 1/20 • Number of events 1 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Vascular disorders Blockage Left Leg	5.0% 1/20 • Number of events 1 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Vascular disorders Fluid Overload	10.0% 2/20 • Number of events 2 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
Vascular disorders Non-Maturing Fistula	5.0% 1/20 • Number of events 1 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.
General disorders Back Pain	5.0% 1/20 • Number of events 1 • The study duration was originally for 1 year. Adverse Events for all 20 subjects were reported for 1 year. Subjects were able to re-consent for an additional year of follow-up and adverse events were/ are being reported for an additional year for all subjects who re-consented. All adverse events were assessed by the site primary investigator and adjudicated by the CEC.

Additional Information

Katy Feeny, Director of Clinical Affairs

Sonavex

Phone: 443-862-2024

Email: KFEENY@SONAVEX.COM

Results disclosure agreements

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

Restriction type: LTE60