Ellipsys Vascular Access System Post Market Surveillance (PS) Study (NCT04484220) | Clinical Trial Compass
CompletedNot Applicable
Ellipsys Vascular Access System Post Market Surveillance (PS) Study
United States142 participantsStarted 2021-04-13
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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
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
What they're measuring
1
Cumulative Patency Through 12 Months Post-AVF Creation
Timeframe: 12 months post-procedure
2
Early Occlusion Rate at 7 Days
Timeframe: 7 days post-procedure
3
Study Related Serious Adverse Event (SAE) Rate Through 12 Months