N/A
N=103
Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD
End Stage Renal Disease · AV Fistula · Fistula · End Stage Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT02363972 ↗Enrolled (actual)
103
Serious AEs
17.5%
Results posted
Sep 2020
Primary outcome: Primary: Maturation Success Rate at 90 Days — 92 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ellipsys Vascular Access Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Endovascular
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maturation Success Rate at 90 Days |
92 | — |
| PRIMARY Number of Participants With Device-related Serious Adverse Events |
— | — |
| SECONDARY Percent of Participants With Access Systems That Successfully Created an AVF |
102 | — |
| SECONDARY Percent of Access Sites With Clinical Patency at Discharge |
98 | — |
| SECONDARY Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days |
29 | — |
| SECONDARY Percent of Access Sites That Achieved or Maintained Maturation at 90 Days |
85 | — |
| SECONDARY Percent of Access Sites That Achieved Maturation Without Intervention |
1 | — |
| SECONDARY Percent of Access Sites That Were Patent Following Intervention |
89 | — |
| SECONDARY Percent of Access Sites That Achieved Patency Without Intervention |
1 | — |
| SECONDARY Intervention Rate |
98 | — |
| SECONDARY Transposition Rate |
19 | — |
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.
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
a. Arterial lumen diameter of ≥ 2.0 mm at target anastomosis site
- Adequate collateral arterial perfusion
- Patent palmar arch
- Negative Allen's Test for ulnar artery insufficiency
- No clinical evidence of subclavian artery stenosis on the ipsilateral side.
- 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 was able to provide written informed consent
- Able to travel to enrolling institution for follow-up examinations
- Able and willing to follow a daily aspirin and/or other anti-coagulation/antiplatelet regimen, not including warfarin (Coumadin, or comparable anti-coagulant, see exclusion criteria 15)
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 10 mg per day
- Peripheral white blood cell count < 1.5 K/mm3 or platelet count < 75,000 cells/mm3
- Current diagnosis of carcinoma (defined as in remission < 1 year)
- Pregnant or currently breast feeding
- Known bleeding diathesis or coagulation disorder
- Receiving warfarin (Coumadin, or comparable anti-coagulant) therapy
- 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 required creation of an arteriovenous fistula distal to the wrist
- Patient required nerve block requiring immobilization of the arm
Data sourced from ClinicalTrials.gov (NCT02363972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.