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 a working dialysis access point in their arm (either a surgically created connection between an artery and vein, called a fistula, or a synthetic tube called a graft) that was created at least 30 days before the study procedure and is currently being used for dialysis
• People who have a blockage or narrowing (at least 50% blocked) in the vein near their dialysis access point, where the narrowed section is no more than 8 cm long and the affected vessel measures between 4.0 mm and 9.0 mm wide
• People who are willing to give written consent before any study procedures begin
• People who are willing to attend all follow-up visits over a 24-month period
• People whose blockage is located at least 3 cm away from the area of the arm used for needle insertion during dialysis
• People whose blockage is located either within the fistula arm (including a specific curve near the shoulder called the cephalic arch) but outside the needle insertion zone, or at or near the point where the artery and vein are connected
• People whose blockage — whether new or a repeat narrowing — is at least 5 cm away from the arterial connection point
• People with one or two blockages that together measure no more than 8 cm in total length, which can be treated with a single stent or overlapping stents as one treatment zone
• People whose blockage could be successfully opened with a balloon before the stent is placed
• People who have at most one additional blockage elsewhere in their dialysis access circuit (at least 10 cm away from the main blockage) that can be treated with balloon widening alone during the same procedure
• People who either have no existing stent in their dialysis access circuit, or have one that has been in place for at least 30 days, is less than 30% blocked, and is at least 5 cm away from the blockage being treated

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant within the next year
• People who have a major surgical or vascular procedure planned within 30 days of the study procedure
• People whose blockage could not be opened with a balloon before stent placement
• People who have a planned surgical revision of their dialysis access site
• People with a known or suspected infection at the dialysis access site, or a widespread body infection or sepsis
• People who are taking medicines that suppress the immune system
• People with a known active blood clotting disorder or tendency to bleed excessively
• People with a known allergy to nickel-titanium alloy, contrast dye, or the drug sirolimus
• People who cannot take blood-thinning or clot-dissolving medications
• People with a known allergy to contrast dye or other medications used during the procedure that cannot be managed with pre-treatment medications
• People with a life expectancy of less than 12 months
• People who have an existing stent anywhere in their dialysis access circuit that is more than 30% blocked or was placed less than 30 days ago
• People whose dialysis access is expected to be discontinued within 6 months
• People who are already enrolled in another clinical trial involving an investigational medicine or device
• People who have a permanent central venous catheter (a tube inserted into a large vein) for dialysis, unless it is being used temporarily as a bridge to treatment with a plan to remove it after a successful dialysis session following the study procedure
• People whose blockage is located inside an existing stent
• People whose treatment would involve the needle insertion zone of the dialysis access
• People whose blockage is less than 5 cm from the arterial connection point
• People who experienced a tear or rupture of the blood vessel during balloon pre-treatment that could not be managed
• People who have an aneurysm (bulge in a vessel), a false aneurysm, or a blood clot that was treated within the last 15 days, at the site of the blockage
• People whose blockage is located — or where the stent would need to be placed — across the elbow joint, in an area where the stent would bend or press against a bone, in the needle insertion zone, inside a pre-existing stent (other than within a synthetic graft), in the leg, in a non-synthetic graft, or in the large central chest veins beyond the cephalic arch
• People whose blockage is positioned in a way that placing a stent would create a kink requiring a bridging stent between the study stent and an existing stent
• People who have more than one additional blockage (at least 50% narrowed) elsewhere in the dialysis access circuit that also needs treatment during the initial procedure

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