Ellipsys Vascular Access System Post Market Surveillance (PS) Study PS200001 Reference DEN170004
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Disease, End Stage
- Sponsor
- Medtronic Endovascular
- Enrollment
- 142
- Locations
- 12
- Primary Endpoint
- Cumulative Patency Through 12 months Post-AVF Creation
- Status
- Completed
- Last Updated
- last year
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.
Investigators
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.
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
Outcomes
Primary Outcomes
Cumulative Patency Through 12 months Post-AVF Creation
Time Frame: 12 months post-procedure
Freedom from access abandonment from time of access creation
Early Occlusion Rate at 7 days
Time Frame: 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
Time Frame: 12 months post-procedure
Rate of serious adverse events through 12 months related to the device, study procedure, or secondary procedure to maintain or re-establish patency.
Secondary Outcomes
- Assisted Primary Patency Through 12 months Post-AVF Creation(12 months post-procedure)
- Overall Patient Safety(12 months post-procedure)
- Primary Patency Through 12 months Post-AVF Creation(12 months post-procedure)
- Secondary Procedures Rate(12 months post-procedure)