AV Fistula, End Stage Kidney Disease, End Stage Renal Disease, Fistula
Conditions
Brief summary
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
Interventions
DEVICEEllipsys Vascular Access Catheter
A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients were eligible for enrollment into the study if they met the following criteria: 1. Patients ≥ 18 years of age and ≤ 80 years of age 2. Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive potential) 3. Life expectancy of at least one year, per the investigator's opinion 4. Diagnosed with end-stage renal disease (ESRD) or chronic kidney disease requiring dialysis or anticipated start of dialysis within 6 months of enrollment 5. Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment 6. Adequate quality vein based on pre-operative assessment 1. Adjacent vein diameter of ≥ 2.0 mm at target anastomosis site 2. Confirmed clinically significant outflow 7. Adequate quality radial artery based on pre-operative assessment a. Arterial lumen diameter of ≥ 2.0 mm at target anastomosis site 8. Adequate collateral arterial perfusion 1. Patent palmar arch 2. Negative Allen's Test for ulnar artery insufficiency 9. No clinical evidence of subclavian artery stenosis on the ipsilateral side. 10. Radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure 11. Patient was able to provide written informed consent 12. Able to travel to enrolling institution for follow-up examinations 13. Able and willing to follow a daily aspirin and/or other anti-coagulation/antiplatelet regimen, not including warfarin (Coumadin, or comparable anti-coagulant, see
Exclusion criteria
15)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device-related Serious Adverse Events | 90 days | The primary safety endpoint was defined as the percent of subjects having one or more of the following device-related serious adverse events: vessel perforation, vessel dissection, and electrical shock during index; and significant embolization in a previously uninvolved arterial territory within 90 days of the index procedure. |
| Maturation Success Rate at 90 Days | 90 days | Maturation success rate of the access site was a binary endpoint defined as (1) achievement of a venous diameter of greater than or equal to 4 mm and (2) blood flow greater than or equal to 500 ml/min as measured via duplex ultrasound at the 90 day follow-up visit for the ITT population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Access Sites With Clinical Patency at Discharge | 90 days | Percent of access sites that demonstrated physical exam patency through clinic discharge |
| Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days | 90 days | Percent of access sites that could sustain three 2-needle cannulations at the prescribed needle gauge and blood flow rate (Qb) between the 4 week and 90 day follow-up visits after initial AV fistula creation |
| Percent of Access Sites That Achieved or Maintained Maturation at 90 Days | 90 days | Percent of access sites which achieved or maintained maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation. This definition also includes common definition for secondary patency. |
| Percent of Access Sites That Achieved Maturation Without Intervention | 90 days | Percent of access sites that achieved and maintained maturation without any surgical or endovascular intervention designed to promote or reestablish maturation |
| Percent of Participants With Access Systems That Successfully Created an AVF | 90 days | Percent of Ellipsys Vascular Access Systems that successfully created an AVF upon deployment |
| Percent of Access Sites That Achieved Patency Without Intervention | 90 days | Percent of access sites that maintained patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site |
| Intervention Rate | 90 days | Percent of subjects who had one or more surgical or endovascular interventions to maintain or reestablish blood flow in the access site |
| Transposition Rate | 90 days | Percent of subjects who required one or more surgical transpositions performed to facilitate needle access |
| Percent of Access Sites That Were Patent Following Intervention | 90 days | Percent of access sites which were patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to First AVF Cannulation | 90 days | Time to AVF cannulation was defined as the elapsed time to the first use of access site (from the date of the study procedure). |
| Target Vessel Location | 90 days | Anatomic location of matured target vessel |
| Catheter Utilization | 90 days | Catheter utilization was defined as the total number of days a catheter was used before access site maturation per subject. The start date was either 1) the date of the study procedure, for subjects who already had a dialysis catheter in place or 2) the date placed, if during the study. The end date was either 1) the date the catheter was removed or 2) the 90 day visit, if the catheter was still in place. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ellipsys Vascular Access Catheter ESRD patients who require and qualify for creation of a surgical AV fistula will be offered the opportunity to participate in this study for a less invasive way of creating an AV fistula.
Ellipsys Vascular Access Catheter: A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae. | 103 |
| Total | 103 |
Baseline characteristics
| Characteristic | Ellipsys Vascular Access Catheter |
|---|---|
| Age, Continuous | 56.6 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 21 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 | 3 Participants |
| Race (NIH/OMB) White | 77 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 28 / 103 |
| serious Total, serious adverse events | 18 / 103 |
Outcome results
Primary
Maturation Success Rate at 90 Days
Maturation success rate of the access site was a binary endpoint defined as (1) achievement of a venous diameter of greater than or equal to 4 mm and (2) blood flow greater than or equal to 500 ml/min as measured via duplex ultrasound at the 90 day follow-up visit for the ITT population.
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ellipsys Vascular Access Catheter | Maturation Success Rate at 90 Days | 92 Participants |
Primary
Number of Participants With Device-related Serious Adverse Events
The primary safety endpoint was defined as the percent of subjects having one or more of the following device-related serious adverse events: vessel perforation, vessel dissection, and electrical shock during index; and significant embolization in a previously uninvolved arterial territory within 90 days of the index procedure.
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ellipsys Vascular Access Catheter | Number of Participants With Device-related Serious Adverse Events | 0 Participants |
Secondary
Intervention Rate
Percent of subjects who had one or more surgical or endovascular interventions to maintain or reestablish blood flow in the access site
Time frame: 90 days
Population: The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ellipsys Vascular Access Catheter | Intervention Rate | 98 Participants |
Secondary
Percent of Access Sites That Achieved Maturation Without Intervention
Percent of access sites that achieved and maintained maturation without any surgical or endovascular intervention designed to promote or reestablish maturation
Time frame: 90 days
Population: The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ellipsys Vascular Access Catheter | Percent of Access Sites That Achieved Maturation Without Intervention | 1 Participants |
Secondary
Percent of Access Sites That Achieved or Maintained Maturation at 90 Days
Percent of access sites which achieved or maintained maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation. This definition also includes common definition for secondary patency.
Time frame: 90 days
Population: The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ellipsys Vascular Access Catheter | Percent of Access Sites That Achieved or Maintained Maturation at 90 Days | 85 Participants |
Secondary
Percent of Access Sites That Achieved Patency Without Intervention
Percent of access sites that maintained patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site
Time frame: 90 days
Population: The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ellipsys Vascular Access Catheter | Percent of Access Sites That Achieved Patency Without Intervention | 1 Participants |
Secondary
Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days
Percent of access sites that could sustain three 2-needle cannulations at the prescribed needle gauge and blood flow rate (Qb) between the 4 week and 90 day follow-up visits after initial AV fistula creation
Time frame: 90 days
Population: The analysis population analyzed (65) is a subset of of the overall number of participants analyzed (103) due to not all participants being on dialysis an requiring 2 needle cannulation by the 90 day outcome measure time frame
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ellipsys Vascular Access Catheter | Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days | 29 Participants |
Secondary
Percent of Access Sites That Were Patent Following Intervention
Percent of access sites which were patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency
Time frame: 90 days
Population: The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ellipsys Vascular Access Catheter | Percent of Access Sites That Were Patent Following Intervention | 89 Participants |
Secondary
Percent of Access Sites With Clinical Patency at Discharge
Percent of access sites that demonstrated physical exam patency through clinic discharge
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ellipsys Vascular Access Catheter | Percent of Access Sites With Clinical Patency at Discharge | 98 Participants |
Secondary
Percent of Participants With Access Systems That Successfully Created an AVF
Percent of Ellipsys Vascular Access Systems that successfully created an AVF upon deployment
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ellipsys Vascular Access Catheter | Percent of Participants With Access Systems That Successfully Created an AVF | 102 Participants |
Secondary
Transposition Rate
Percent of subjects who required one or more surgical transpositions performed to facilitate needle access
Time frame: 90 days
Population: The analysis population analyzed (102) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ellipsys Vascular Access Catheter | Transposition Rate | 19 Participants |
Other Pre-specified
Catheter Utilization
Catheter utilization was defined as the total number of days a catheter was used before access site maturation per subject. The start date was either 1) the date of the study procedure, for subjects who already had a dialysis catheter in place or 2) the date placed, if during the study. The end date was either 1) the date the catheter was removed or 2) the 90 day visit, if the catheter was still in place.
Time frame: 90 days
Population: The analysis population analyzed (32) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure and not requiring a catheter utilization by the 90 day outcome timeframe
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ellipsys Vascular Access Catheter | Catheter Utilization | 83.1 days | Standard Deviation 17.4 |
Other Pre-specified
Target Vessel Location
Anatomic location of matured target vessel
Time frame: 90 days
Population: The analysis population analyzed (90) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure and not achieving an identifiable target vein by the 90 day outcome timeframe
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ellipsys Vascular Access Catheter | Target Vessel Location | Cephalic vein | 68 Participants |
| Ellipsys Vascular Access Catheter | Target Vessel Location | Basilic vein | 20 Participants |
| Ellipsys Vascular Access Catheter | Target Vessel Location | Brachial vein 1 | 1 Participants |
| Ellipsys Vascular Access Catheter | Target Vessel Location | Brachial vein 2 | 1 Participants |
Other Pre-specified
Time to First AVF Cannulation
Time to AVF cannulation was defined as the elapsed time to the first use of access site (from the date of the study procedure).
Time frame: 90 days
Population: The analysis population analyzed (33) is a subset of of the overall number of participants analyzed (103) due to not all participants having a patent fistula at discharge from the index procedure and not requiring cannulation by the 90 day outcome timeframe
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ellipsys Vascular Access Catheter | Time to First AVF Cannulation | 67.8 Days | Standard Deviation 15.9 |