Clinical trial NCT04484220: Ellipsys Vascular Access System Post Market Surveillance (PS) Study
Official title: Ellipsys Vascular Access System Post Market Surveillance (PS) Study PS200001 Reference DEN170004
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Disease, End Stage
Kidney Disease, End-Stage
AV Fistula
Fistulas Arteriovenous
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2020-07-23
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative Patency Through 12 months Post-AVF Creation
timeFrame: 12 months post-procedure
measure: Early Occlusion Rate at 7 days
timeFrame: 7 days post-procedure
measure: Study Related Serious Adverse Event (SAE) Rate Through 12 months
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Primary Patency Through 12 months Post-AVF Creation
timeFrame: 12 months post-procedure
measure: Assisted Primary Patency Through 12 months Post-AVF Creation
timeFrame: 12 months post-procedure
measure: Secondary Procedures Rate
timeFrame: 12 months post-procedure
measure: Overall Patient Safety
timeFrame: 12 months post-procedure
Other outcomes:
Locations:
city: Riverside
country: United States
facility: Nephrology Associates Access Center
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: Azura Vascular Care, Jacksonville
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular and Interventional, PLLC
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Hyannis
country: United States
facility: The Vascular Care Group
state: Massachusetts
city: Las Vegas
country: United States
facility: Nephrology Kidney Disease Hypertension Center
state: Nevada
city: Staten Island
country: United States
facility: Staten Island Hospital
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburg Medical Center
state: Pennsylvania
city: San Antonio
country: United States
facility: STAR Vascular Access Center
state: Texas
city: San Antonio
country: United States
facility: San Antonio Kidney Disease Center
state: Texas
city: North Chesterfield
country: United States
facility: Richmond Vascular Center
state: Virginia
Study officials:
affiliation: Rush University Medical Center
name: Haimanot Wasse, MD
role: PRINCIPAL_INVESTIGATOR
References: