AV Fistula, Fistulas Arteriovenous, Kidney Disease, End-Stage, Renal Disease, End Stage
Conditions
Brief summary
The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.
Detailed description
The primary objective of this post-market surveillance study is to support the short-term safety of the device and procedure and further assess long-term safety and effectiveness in subjects treated by newly trained providers of the Ellipsys Vascular Access System in the creation of a native AV fistula via percutaneous access in subjects who are on hemodialysis and are medically indicated for the creation of an upper limb anastomosis.
Interventions
DEVICEEllipsys Vascular Access System
The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or non-pregnant female ≥ 18 years of age and ≤ 80 years of age 2. Life expectancy of at least one year, in the investigator's opinion 3. Diagnosed with ESRD or chronic kidney disease on hemodialysis. 4. Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment 5. 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 6. Adequate quality radial artery based on pre-operative assessment a. Arterial lumen diameter of ≥2.0 mm at target anastomosis site 7. Adequate collateral arterial perfusion with patent palmar arch as demonstrated by Barbeau Test or Allen's Test. 8. Radial artery-adjacent vein proximity ≤1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure 9. Patient is able to provide written informed consent and attend follow-up examinations at the enrolling institution Imaging-based Inclusion Criteria: 10. Confirm radial artery-adjacent vein proximity ≤1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedurally 11. Confirm radial artery and adjacent vein diameter of ≥2.0 mm at target anastomosis site
Exclusion criteria
1. Pre-existing ipsilateral vascular disease interfering with the study procedure or potentially confounding the study results including: 1. Documented or suspected central venous stenosis (≥ 50%) or 2. Upper extremity arterial stenosis or 3. Vascular disease at the radial artery / adjacent vein site 2. Prior vascular surgery at or proximal (central) to the AVF target site interfering with AVF maturation or other ipsilateral surgery that could potentially confound the study results such as prior axillary dissection or mastectomy 3. History of steal syndrome from a previous surgical ipsilateral hemodialysis vascular access which required intervention or abandonment 4. Systolic pressures \< 100 mg Hg at the time of screening 5. Suspected or confirmed skin disease at the skin entry site 6. Edema of the upper extremity on the ipsilateral side 7. Immunocompromised subjects due to underlying disease or immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of \> 10 mg per day 8. Known bleeding diathesis, coagulation disorder or medications putting the subject at increased risk, in the Investigator's judgment 9. Patients with acute or active infection 10. Scheduled kidney transplant within 6 months of enrollment 11. Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form) 12. History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment 13. Patient has an active COVID-19 infection with ongoing sequela or hospitalization for treatment of COVID-19.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Patency Through 12 Months Post-AVF Creation | 12 months post-procedure | Freedom from access abandonment from time of access creation |
| Early Occlusion Rate at 7 Days | 7 days post-procedure | Percent of patients with total occlusion within 7 days of the AVF creation procedure |
| Study Related Serious Adverse Event (SAE) Rate Through 12 Months | 12 months post-procedure | This event rate is reported as the percentage of participants with at least one Serious Adverse Event through 12 Months, related to the device, study procedure, or secondary procedure to maintain or re-establish patency. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency Through 12 Months Post-AVF Creation | 12 months post-procedure | Freedom from access thrombosis or any intervention designed to facilitate, maintain or re-establish patency measured from time of access creation through 12 months |
| Assisted Primary Patency Through 12 Months Post-AVF Creation | 12 months post-procedure | Freedom from access thrombosis from time of access creation through 12 months post-AVF creation |
| Secondary Procedures Rate, Per Person Years | 12 months post-procedure | Secondary procedure rate will be summarized cumulatively through 12 months as the number of procedures per person-years as well as the number and percentage of subjects having one or more procedures in the Treated population (see 8. Secondary Outcome Measure). |
| Overall Patient Safety-Serious, Device-Related, Procedure-Related, Secondary Procedure-Related and/or Cannulation-Related Adverse Events | 12 months post-procedure | A full characterization of adverse events during the study |
| Secondary Procedures Rate, Percentage of Subjects | 12 months post-procedure | Secondary procedure rate will be summarized cumulatively through 12 months as the number of procedures per person-years as well as the number and percentage of subjects having one or more procedures in the Treated population. (see 6. Secondary Outcome Measure) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHaimanot Wasse, MD
Rush University Medical Center
Participant flow
Pre-assignment details
142 subjects signed Informed Consent and make up the "started" group. 11 subjects did not have or did not attempt to have the study device deployed. This is how the Safety population of 131 subjects value was calculated (142-11=131).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 14.1 |
| Body Mass Index (BMI) | 29.3 kg/m2 STANDARD_DEVIATION 6.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 61 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants |
| Race (NIH/OMB) White | 98 Participants |
| Region of Enrollment United States | 131 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 131 |
| other Total, other adverse events | 3 / 131 |
| serious Total, serious adverse events | 55 / 131 |
Outcome results
None listed