Chronic Kidney Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have kidney failure requiring dialysis through a blood vessel access point, or who have chronic kidney disease and are expected to need dialysis within 6 months
• People who have a specific vein in the arm (the cubital perforating vein) measuring between 2.0 and 5.0 mm wide
• People who have a specific artery in the arm (the proximal radial artery) measuring between 2.0 and 4.0 mm wide
• People aged between 18 and 79 years old
• People who are willing and mentally able to sign a written consent form
• People who are willing and able to attend all study visits and complete all follow-up requirements

Who may not be able to join:

• People whose blood pressure in the arm being studied is below 100 mmHg
• People who have a blockage in either of the main arteries in the forearm (ulnar or radial artery), or who have an abnormal result on a circulation test called Allen's test
• People who have previously had an artificial blood vessel graft or an upper arm vein-artery connection (AVF) on the same arm being studied
• People where the distance between the two specific blood vessels being used is greater than 3.0 mm
• People where a vein called the cephalic vein measures less than 2.5 mm wide at any point along a specific section of the arm
• People who have a blockage in a large vein in the chest on the same side as the arm being studied
• People who have heavy calcium build-up in the radial artery that makes it difficult to see clearly on ultrasound, which could make the procedure unsafe (confirm with trial site)
• People who have had an active infection anywhere in the body, or at the procedure site, within the past 7 days
• People with a history of serious heart disease (classified as NYHA Class III or IV), a heart attack within the past 6 months, a serious ongoing heart rhythm problem, or unstable chest pain
• People who cannot take blood-thinning medications called antiplatelet therapy for any reason
• People who are currently taking part in another clinical trial involving an experimental drug or device
• People who have had known serious reactions to sedation or anaesthesia that cannot be managed with pre-treatment medication
• People with poorly controlled diabetes, defined as a blood sugar control reading (HbA1c) above 10%
• People with a known condition that causes abnormal blood clotting, either clotting too easily or bleeding too much
• People who have swelling caused by a lymphatic problem (lymphedema) in the arm being studied
• People who have a kidney transplant scheduled within 6 months of joining the trial
• People whose white blood cell count or neutrophil levels fall outside specified ranges, which may indicate an immune system problem (confirm with trial site)
• People whose platelet count is below 75,000 cells per microlitre
• People with a current cancer diagnosis, unless they have been in remission for more than 1 year
• People who are pregnant or currently breastfeeding
• People who have a known allergy to nickel, nickel-titanium alloy (also called NiTi or Nitinol), or any component of the device being studied
• People with any other medical condition that the trial doctor believes could put their health at risk or affect the reliability of the study results
• People whose arm anatomy is found to be unsuitable for the study device before the procedure begins

Important: Always verify eligibility with the trial site directly before applying.