Arteriovenous Fistula, Kidney Diseases
Conditions
Brief summary
Multi-center trial to assess the feasibility and safety of the EchoMark LP and the EchoMark diagnostic ultrasound system for assessing AV fistula blood flow, diameter, and depth.
Detailed description
This is a prospective, multi-center, single-arm, non-blinded clinical trial designed to evaluate the feasibility and safety of the EchoMark and the EchoSure in subjects undergoing new upper arm autologous arteriovenous fistula creation who require hemodialysis. All subjects will provide informed consent prior to undergoing any study procedures. The study will consists of multiple follow-up visits during the 52 week duration. Subjects are able to re-consent and remain in follow-up for an additional year.
Interventions
DEVICEEchoMark / EchoSure
The EchoMark is to be secured a minimum of 3 cm away from the anastomosis. The follow-up EchoSure scans will be conducted by the designated EchoSure user without the investigator and without the sonographer/RVT conducting the Duplex exam in the room, either during the routine work-up prior to the surgeon seeing the patient or after. The EchoSure results for flow, and vessel depth and diameter are shown as numerical values on the screen of the EchoSure device.
Sponsors
Sonavex, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but \< 85 years of age at the time of informed consent 2. Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures 3. Subject is willing and capable of complying with all required follow-up visits 4. Subject and/or Care Team agree that the distance and transportation resources from the subject's home to the clinic are reasonable for study participation and compliance 5. Subject has an estimated life expectancy \> 18 months 6. Subject is ambulatory (cane or walker are acceptable) 7. Subjects presenting for upper arm autologous arteriovenous fistula creation 8. Vein diameter \> 2.5 mm at the antecubital fossa via imaging 9. Artery diameter \> 3 mm via imaging 10. Subject is not participating in another investigational clinical trial that has not met its primary endpoint. Participation in a post-market registry is acceptable.
Exclusion criteria
1. Subjects receiving a forearm fistula. 2. Subject has history of Steal Syndrome. 3. Subject who is immunocompromised or immunosuppressed. 4. Subject has had three previous failed AV fistulae for hemodialysis access 5. Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation. 6. Known or suspected active infection on the day of the index procedure. 7. Subjects who had infection(s) in the 30-day window prior to EchoMark placement to reduce the likelihood of partially treated infections that can seed the device and fistula 8. Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count \<50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access 9. Subjects with active malignancy 10. Subjects with a history of poor compliance with the dialysis protocol 11. Subjects with a known or suspected allergy to any of the device materials 12. Subjects with an existing fistula or graft 13. Subjects who are pregnant, plan to become pregnant, or are breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 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 |
| Primary Feasibility Endpoint | 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. |
| 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | EchoMark |
|---|---|
| Age, Continuous | 64.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 20 |
| other Total, other adverse events | 16 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Primary Feasibility Endpoint
Rate of Technical Success defined as the successful implantation of the EchoMark implant. Technical success will be assessed from baseline to 4 months.
Time frame: 4 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EchoMark | Primary Feasibility Endpoint | 20 Participants |
Primary
Primary Safety Endpoint
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
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark | Primary Safety Endpoint | 0 MAES within 30 days post baseline visit |
Primary
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.
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.
Time frame: 4 Months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| EchoMark | 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
Clinical Maturation Success Rate
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EchoMark | Clinical Maturation Success Rate | 7 Participants |
Other Pre-specified
Comparison of EchoSure and Duplex Measurements of Depth
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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EchoMark | Comparison of EchoSure and Duplex Measurements of Depth | 18.4 Depth Percent Difference | Standard Deviation 23.8 |
Other Pre-specified
Comparison of EchoSure and Duplex Measurements of Diameter
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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EchoMark | Comparison of EchoSure and Duplex Measurements of Diameter | 9.4 Diameter Percent Difference | Standard Deviation 19.7 |
Other Pre-specified
Comparison of EchoSure and Duplex Measurements Using Percentages
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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EchoMark | Comparison of EchoSure and Duplex Measurements Using Percentages | -7.8 Flow Rate Percent Difference | Standard Deviation 38.5 |
Other Pre-specified
Comparison of EchoSure Depth Measurements to Independent Reviewer Measured Depth Results.
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.
Time frame: 4 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EchoMark | Comparison of EchoSure Depth Measurements to Independent Reviewer Measured Depth Results. | 18.4 Depth Percent Difference | Standard Deviation 23.8 |
Other Pre-specified
Composite of New Major Device Related Adverse Events (MAEs) at 12 Months Post EchoMark LP Implantation, as Adjudicated by the Clinical Events Committee (CEC).
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
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EchoMark | 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 |
Other Pre-specified
Number of Patients With 12-Month Patency
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).
Time frame: 12 Months
Population: Subjects who completed the 12-month visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EchoMark | Number of Patients With 12-Month Patency | 16 Participants |
Other Pre-specified
Number of Patients With 6-Month Patency
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).
Time frame: 6 Months
Population: Subjects who completed the 6-month visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EchoMark | Number of Patients With 6-Month Patency | 16 Participants |
Other Pre-specified
Occurrence of Events Occurring Within 30 Days of Implantation That Require Reinterventions (Open or Endovascular), Hospitalizations, or Prolongation of Existing Hospitalization.
Time frame: 30 Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark | 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
Occurrence of Events of Bleeding Requiring Surgical Intervention (Including PRBC Transfusion) From Baseline to 12 Months.
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark | Occurrence of Events of Bleeding Requiring Surgical Intervention (Including PRBC Transfusion) From Baseline to 12 Months. | 0 Events |
Other Pre-specified
Occurrence of Events of Hematoma Requiring Procedural Intervention From Baseline to 12 Months.
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark | Occurrence of Events of Hematoma Requiring Procedural Intervention From Baseline to 12 Months. | 0 Events |
Other Pre-specified
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
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark | 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
Occurrence of Events of Infection (Not Limited to Infection Requiring Implant Explanation) From Baseline to 12 Months
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark | Occurrence of Events of Infection (Not Limited to Infection Requiring Implant Explanation) From Baseline to 12 Months | 0 Events |
Other Pre-specified
Occurrence of Events of Infiltration Requiring Procedural Intervention From Baseline to 12 Months.
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark | Occurrence of Events of Infiltration Requiring Procedural Intervention From Baseline to 12 Months. | 2 Events |
Other Pre-specified
Occurrence of Events of Pain Related to the Study Devices From Baseline to 12 Months
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark | Occurrence of Events of Pain Related to the Study Devices From Baseline to 12 Months | 1 Events |
Other Pre-specified
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.
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark | 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
Occurrence of Events of the Development of Steal Syndrome From Baseline to 12 Months.
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark | Occurrence of Events of the Development of Steal Syndrome From Baseline to 12 Months. | 1 Events |
Other Pre-specified
Occurrence of Events of the Inability to Use the EchoSure Component of the System From Baseline to 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.
Time frame: 4 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark | Occurrence of Events of the Inability to Use the EchoSure Component of the System From Baseline to 4 Months | 0 Events |
Other Pre-specified
Occurrence of the Reported Inability to Cannulate Fistula Beginning Once the Fistula is Deemed Radiographically and Clinically Mature to 12 Months.
Time frame: 12 Months
Population: Subjects that have been deemed clinically mature
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EchoMark | 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
Radiographic Maturation Success Rate
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.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EchoMark | Radiographic Maturation Success Rate | 19 Participants |
Other Pre-specified
Time to Clinical Maturation
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.
Time frame: 12 Months
Population: Analysis included subjects with supporting cannulation records
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EchoMark | Time to Clinical Maturation | 67.5 Number of Days | Standard Deviation 4.9 |
Other Pre-specified
Time to Radiographic 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.
Time frame: 12 Months
Population: One subject never reached clinical maturation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EchoMark | Time to Radiographic Maturation | 28.8 Number of Days | Standard Deviation 23.4 |