Ellipsys Vascular Access System Post Market Surveillance (PS) Study

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT04484220

Run by

Medtronic Endovascular

People needed

142

Starts

2021-04-13

Expected to finish

2025-03-31

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Nephrology Associates Access Center — Riverside, California, United States
• Yale University — New Haven, Connecticut, United States
• Azura Vascular Care, Jacksonville — Jacksonville, Florida, United States
• Coastal Vascular and Interventional, PLLC — Pensacola, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• The Vascular Care Group — Hyannis, Massachusetts, United States
• Nephrology Kidney Disease Hypertension Center — Las Vegas, Nevada, United States
• Staten Island Hospital — Staten Island, New York, United States
• University of Pittsburg Medical Center — Pittsburgh, Pennsylvania, United States
• STAR Vascular Access Center — San Antonio, Texas, United States
• San Antonio Kidney Disease Center — San Antonio, Texas, United States
• Richmond Vascular Center — North Chesterfield, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.