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 aged 18 or older
• People whose doctor has determined they need a new connection between an artery and vein (called an AVF) created at the wrist or lower forearm for dialysis access
• People with end-stage kidney disease who are currently receiving regular hemodialysis (kidney dialysis)
• People who have a specific vein in the lower forearm (called the cephalic vein) that measures between 1.7 mm and 3.2 mm wide at the planned surgery site, is at least 14 cm long with a clear 10 cm usable stretch, has no blockages or narrowing, and connects through to the upper arm through one of several accepted pathways (confirm with trial site)
• People with a radial artery (a blood vessel in the wrist area) that can be felt by touch, measures at least 2.0 mm wide, and has no major narrowing along its length
• People who pass a standard hand circulation test called Allen's Test
• People who have at least one usable jugular vein in the neck suitable for placement of part of the trial device
• People who have voluntarily signed a written consent form agreeing to participate

Who may not be able to join:

• People with a known allergy to any components of the trial device (polyurethane or nitinol), iodinated contrast dye, heparin, or the blood-thinning medication apixaban
• People with a known or suspected active infection at the time the trial device would be placed
• People with known bleeding disorders, including uncorrected problems with blood clotting
• People with a known clotting disorder (thrombophilia) that requires treatment
• People with a hemoglobin (red blood cell) level below 7 g/dL (a measure of anaemia)
• People with a platelet count below 100,000 per mm³ (platelets help blood clot)
• People with significant calcium build-up in the radial artery at the wrist
• People who need to continue taking blood-thinning or anti-platelet medications other than apixaban during the trial treatment period
• People with a known heart condition called a patent foramen ovale larger than 2 mm (a small opening between the upper chambers of the heart)
• People with a recent history of bleeding in the brain or digestive system
• People with a recently detected blood clot in a central vein or in the right side of the heart
• People with an existing condition that would increase the risk of bleeding inside the brain or body
• People who have recently had a blockage, significant narrowing, balloon procedure, or stent placed in a central vein on the same side of the body as the planned procedure
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial
• People whose expected survival is less than 12 months
• People who are unwilling or unable to follow the trial procedures or attend required follow-up visits
• People currently participating in another clinical trial involving an investigational drug or device that has not finished, or who plan to join such a trial before this study is complete

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