N/A Completed N=103 Treatment

Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

End Stage Renal Disease · AV Fistula · Fistula · End-stage kidney disease

Source: ClinicalTrials.gov NCT02363972 ↗

Enrolled (actual)

103

Serious AEs

17.5%

Results posted

Sep 2020

Primary outcomePrimary: Maturation Success Rate at 90 Days — 92 Participants

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.