Ellipsys Vascular Access System Post Market Surveillance (PS) Study

Study Overview
=================
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.

Official Title
-----------------
Ellipsys Vascular Access System Post Market Surveillance (PS) Study PS200001 Reference DEN170004

Conditions
-----------------
Renal Disease, End Stage, Kidney Disease, End-Stage, AV Fistula, Fistulas Arteriovenous

Intervention / Treatment
-----------------
* Device: Ellipsys Vascular Access System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant female ≥ 18 years of age and ≤ 80 years of age Life expectancy of at least one year, in the investigator's opinion Diagnosed with ESRD or chronic kidney disease on hemodialysis. Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment Adequate quality vein based on pre-operative assessment Adjacent vein diameter of ≥2.0 mm at target anastomosis site Confirmed clinically significant outflow Adequate quality radial artery based on pre-operative assessment a. Arterial lumen diameter of ≥2.0 mm at target anastomosis site Adequate collateral arterial perfusion with patent palmar arch as demonstrated by Barbeau Test or Allen's Test. Radial artery-adjacent vein proximity ≤1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure Patient is able to provide written informed consent and attend follow-up examinations at the enrolling institution Imaging-based Inclusion Criteria: 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 Confirm radial artery and adjacent vein diameter of ≥2.0 mm at target anastomosis site Exclusion Criteria: Pre-existing ipsilateral vascular disease interfering with the study procedure or potentially confounding the study results including: Documented or suspected central venous stenosis (≥ 50%) or Upper extremity arterial stenosis or Vascular disease at the radial artery / adjacent vein site 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 History of steal syndrome from a previous surgical ipsilateral hemodialysis vascular access which required intervention or abandonment Systolic pressures < 100 mg Hg at the time of screening Suspected or confirmed skin disease at the skin entry site Edema of the upper extremity on the ipsilateral side Immunocompromised subjects due to underlying disease or immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of > 10 mg per day Known bleeding diathesis, coagulation disorder or medications putting the subject at increased risk, in the Investigator's judgment Patients with acute or active infection Scheduled kidney transplant within 6 months of enrollment Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form) History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment Patient has an active COVID-19 infection with ongoing sequela or hospitalization for treatment of COVID-19.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ellipsys Vascular Access System<br>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 who have chronic kidney disease requiring dialysis. | Device: Ellipsys Vascular Access System<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Patency Through 12 months Post-AVF Creation | Freedom from access abandonment from time of access creation | 12 months post-procedure | 
| Early Occlusion Rate at 7 days | Percent of patients with total occlusion within 7 days of the AVF creation procedure | 7 days post-procedure | 
| Study Related Serious Adverse Event (SAE) Rate Through 12 months | Rate of serious adverse events through 12 months related to the device, study procedure, or secondary procedure to maintain or re-establish patency. | 12 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency Through 12 months Post-AVF Creation | Freedom from access thrombosis or any intervention designed to facilitate, maintain or re-establish patency measured from time of access creation through 12 months | 12 months post-procedure | 
| Assisted Primary Patency Through 12 months Post-AVF Creation | Freedom from access thrombosis from time of access creation | 12 months post-procedure | 
| Secondary Procedures Rate | Number of surgical or percutaneous interventions designed to mature or maintain the AVF or re-establish flow per person-year. | 12 months post-procedure | 
| Overall Patient Safety | A full characterization of adverse events during the study | 12 months post-procedure |