Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD

Completed · Not applicable

Conditions studied: End Stage Renal Disease, AV Fistula, Fistula, End Stage Kidney Disease

In brief

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.

Key facts

Study ID

NCT02363972

Run by

Medtronic Endovascular

People needed

103

Starts

2015-02-10

Expected to finish

2016-06-01

Last updated by the study team

2021-11-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• Patients requiring immunosuppressant therapy such as sirolimus (Rapamune®) or Prednisone at a dose of > 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

Where it is running

• Southwest Vascular Center — Tempe, Arizona, United States
• BNMG San Diego Vascular Access Center — San Diego, California, United States
• Dallas Nephrology Associates — Plano, Texas, United States
• San Antonio Kidney Disease Center — San Antonio, Texas, United States
• Richmond Vascular Center — North Chesterfield, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.