Clinical trial NCT02363972: Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD
Official title: Ellipsys Vascular Access Catheter System Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
AV Fistula
Fistula
End Stage Kidney Disease
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2015-02-16
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

Patients were eligible for enrollment into the study if they met the following criteria:

1. Patients ≥ 18 years of age and ≤ 80 years of age
2. Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive potential)
3. Life expectancy of at least one year, per the investigator's opinion
4. Diagnosed with end-stage renal disease (ESRD) or chronic kidney disease requiring dialysis or anticipated start of dialysis within 6 months of enrollment
5. Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment
6. Adequate quality vein based on pre-operative assessment

   1. Adjacent vein diameter of ≥ 2.0 mm at target anastomosis site
   2. Confirmed clinically significant outflow
7. Adequate quality radial artery based on pre-operative assessment

   a. Arterial lumen diameter of ≥ 2.0 mm at target anastomosis site
8. Adequate collateral arterial perfusion

   1. Patent palmar arch
   2. Negative Allen's Test for ulnar artery insufficiency
9. No clinical evidence of subclavian artery stenosis on the ipsilateral side.
10. Radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by pre-procedural ultrasound and confirmed pre-procedure
11. Patient was able to provide written informed consent
12. Able to travel to enrolling institution for follow-up examinations
13. 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:

1. Documented or suspected central venous stenosis including upper extremity arterial stenosis (≥ 50%)
2. 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
3. History of steal syndrome from a previous hemodialysis vascular access on the ipsilateral side which required intervention or abandonment
4. Evidence of vascular disease at the radial artery/adjacent vein site on the ipsilateral side
5. Pre-existing vascular disease that could confound the study results
6. Systolic pressures \< 100 mm Hg at the time of screening
7. Suspected or confirmed skin disease at the skin entry site
8. Immunocompromised patients (e.g. HIV positive)
9. Edema of the upper extremity on the ipsilateral side
10. Patients requiring immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of \> 10 mg per day
11. Peripheral white blood cell count \< 1.5 K/mm3 or platelet count \< 75,000 cells/mm3
12. Current diagnosis of carcinoma (defined as in remission \< 1 year)
13. Pregnant or currently breast feeding
14. Known bleeding diathesis or coagulation disorder
15. Receiving warfarin (Coumadin, or comparable anti-coagulant) therapy
16. Patients with acute or active infection
17. Scheduled kidney transplant within 6 months of enrollment
18. Participation in another clinical investigation (excluding retrospective studies or studies not requiring a consent form)
19. History of substance abuse or anticipated to be non-compliant with medical care or study requirements based on investigator judgment
20. Patient required creation of an arteriovenous fistula distal to the wrist
21. Patient required nerve block requiring immobilization of the arm

Primary outcomes:
measure: Maturation Success Rate at 90 Days
timeFrame: 90 days
measure: Number of Participants With Device-related Serious Adverse Events
timeFrame: 90 days
Secondary outcomes:
measure: Percent of Participants With Access Systems That Successfully Created an AVF
timeFrame: 90 days
measure: Percent of Access Sites With Clinical Patency at Discharge
timeFrame: 90 days
measure: Percent of Access Sites That Sustain 2-needle Cannulation by 90 Days
timeFrame: 90 days
measure: Percent of Access Sites That Achieved or Maintained Maturation at 90 Days
timeFrame: 90 days
measure: Percent of Access Sites That Achieved Maturation Without Intervention
timeFrame: 90 days
measure: Percent of Access Sites That Were Patent Following Intervention
timeFrame: 90 days
measure: Percent of Access Sites That Achieved Patency Without Intervention
timeFrame: 90 days
measure: Intervention Rate
timeFrame: 90 days
measure: Transposition Rate
timeFrame: 90 days
Other outcomes:
measure: Time to First AVF Cannulation
timeFrame: 90 days
measure: Catheter Utilization
timeFrame: 90 days
measure: Target Vessel Location
timeFrame: 90 days
Locations:
city: Tempe
country: United States
facility: Southwest Vascular Center
state: Arizona
city: San Diego
country: United States
facility: BNMG San Diego Vascular Access Center
state: California
city: Plano
country: United States
facility: Dallas Nephrology Associates
state: Texas
city: San Antonio
country: United States
facility: San Antonio Kidney Disease Center
state: Texas
city: North Chesterfield
country: United States
facility: Richmond Vascular Center
state: Virginia
Study officials:
affiliation: Richmond Vascular Center
name: Jeffrey Hull, MD
role: PRINCIPAL_INVESTIGATOR
References: