| 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
| | Posted | | Number | | MAES within 30 days post baseline visit | | 30 Days | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| 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. | | Posted | | Count of Participants | | Participants | | 4 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | | Posted | | Count of Units | | EchoSure Scans | | 4 Months | EchoSure Scans | EchoSure Scans | | ID | Title | Description |
|---|
| OG000 | 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. 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. |
| |
| 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. | | Posted | | Mean | Standard Deviation | Flow Rate Percent Difference | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | | Posted | | Mean | Standard Deviation | Diameter Percent Difference | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. 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. |
| |
| 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. | | Posted | | Mean | Standard Deviation | Depth Percent Difference | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | | Posted | | Mean | Standard Deviation | Depth Percent Difference | | 4 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | One subject never reached clinical maturation | Posted | | Mean | Standard Deviation | Number of Days | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | Analysis included subjects with supporting cannulation records | Posted | | Mean | Standard Deviation | Number of Days | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | | Posted | | Count of Participants | | Participants | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 17 subjects were cleared for cannulation and source documents were requested. 2 subjects did not require dialysis treatment. Records were obtained for 7 Subjects. | Posted | | Count of Participants | | Participants | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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). | Subjects who completed the 6-month visit. | Posted | | Count of Participants | | Participants | | 6 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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). | Subjects who completed the 12-month visit | Posted | | Count of Participants | | Participants | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Other Pre-specified | Occurrence of Events Occurring Within 30 Days of Implantation That Require Reinterventions (Open or Endovascular), Hospitalizations, or Prolongation of Existing Hospitalization. | | | Posted | | Number | | Events | | 30 Days | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| 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. | | | Posted | | Number | | Events | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Other Pre-specified | Occurrence of the Reported Inability to Cannulate Fistula Beginning Once the Fistula is Deemed Radiographically and Clinically Mature to 12 Months. | | Subjects that have been deemed clinically mature | Posted | | Number | | Occurrence of Event | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Other Pre-specified | Occurrence of Events of the Development of Steal Syndrome From Baseline to 12 Months. | | | Posted | | Number | | Events | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Other Pre-specified | Occurrence of Events of Bleeding Requiring Surgical Intervention (Including PRBC Transfusion) From Baseline to 12 Months. | | | Posted | | Number | | Events | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Other Pre-specified | Occurrence of Events of Infiltration Requiring Procedural Intervention From Baseline to 12 Months. | | | Posted | | Number | | Events | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Other Pre-specified | Occurrence of Events of Hematoma Requiring Procedural Intervention From Baseline to 12 Months. | | | Posted | | Number | | Events | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Other Pre-specified | Occurrence of Events of the Inability to Use the EchoSure Component of the System From Baseline to 4 Months | Due to:
- Migration of the EchoMark device
- Early resorption of the EchoMark device as defined as breakdown of the EchoMark shape prior to 4 months from index procedure.
| | Posted | | Number | | Events | | 4 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Other Pre-specified | Occurrence of Events of Pain Related to the Study Devices From Baseline to 12 Months | | | Posted | | Number | | Events | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| Other Pre-specified | Occurrence of Events of Infection (Not Limited to Infection Requiring Implant Explanation) From Baseline to 12 Months | | | Posted | | Number | | Events | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| 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 | | | Posted | | Number | | Events | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | |
| 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
| | Posted | | Count of Participants | | Participants | | 12 Months | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |