Ellipsys Vascular Access Catheter System Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- End Stage Renal Disease
- Sponsor
- Medtronic Endovascular
- Enrollment
- 103
- Locations
- 5
- Primary Endpoint
- Maturation Success Rate at 90 Days
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients were eligible for enrollment into the study if they met the following criteria:
- •Patients ≥ 18 years of age and ≤ 80 years of age
- •Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive potential)
- •Life expectancy of at least one year, per the investigator's opinion
- •Diagnosed with end-stage renal disease (ESRD) or chronic kidney disease requiring dialysis or anticipated start of dialysis within 6 months of enrollment
- •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
- •Patients were excluded if any of the following was true:
- •Documented or suspected central venous stenosis including upper extremity arterial stenosis (≥ 50%)
- •a. Prior vascular surgery at or proximal (central) to the AVF target site b. Prior axillary dissection or mastectomy on the ipsilateral side as intended AV fistula site
- •History of steal syndrome from a previous hemodialysis vascular access on the ipsilateral side which required intervention or abandonment
- •Evidence of vascular disease at the radial artery/adjacent vein site on the ipsilateral side
- •Pre-existing vascular disease that could confound the study results
- •Systolic pressures \< 100 mm Hg at the time of screening
- •Suspected or confirmed skin disease at the skin entry site
- •Immunocompromised patients (e.g. HIV positive)
- •Edema of the upper extremity on the ipsilateral side
Outcomes
Primary Outcomes
Maturation Success Rate at 90 Days
Time Frame: 90 days
Maturation success rate of the access site was a binary endpoint defined as (1) achievement of a venous diameter of greater than or equal to 4 mm and (2) blood flow greater than or equal to 500 ml/min as measured via duplex ultrasound at the 90 day follow-up visit for the ITT population.
Number of Participants With Device-related Serious Adverse Events
Time Frame: 90 days
The primary safety endpoint was defined as the percent of subjects having one or more of the following device-related serious adverse events: vessel perforation, vessel dissection, and electrical shock during index; and significant embolization in a previously uninvolved arterial territory within 90 days of the index procedure.
Secondary Outcomes
- Percent of Access Sites That Achieved or Maintained Maturation at 90 Days(90 days)
- Percent of Access Sites That Were Patent Following Intervention(90 days)
- Intervention Rate(90 days)
- Percent of Access Sites That Achieved Maturation Without Intervention(90 days)
- Percent of Participants With Access Systems That Successfully Created an AVF(90 days)
- Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days(90 days)
- Percent of Access Sites With Clinical Patency at Discharge(90 days)
- Percent of Access Sites That Achieved Patency Without Intervention(90 days)
- Transposition Rate(90 days)