A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV (NCT04226599) | Clinical Trial Compass
CompletedNot Applicable
A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV
China220 participantsStarted 2019-07-23
Plain-language summary
Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia, therefore, it represents an attractive option for AVF stenoses. This trial is aimed to evaluate the safety and efficacy of Peripheral scoring drug balloon (Dissolve AV) or Balloon Dilatation catheter ( Armada 35) in treating AVF stenosis in chinese population.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 18-75 years (inclusive), male or female;
✓. Patients with mature AVF/AVG and at least one successful hemodialysis session;
✓. Target lesion located in the AVF/AVG reflux vein (excluding the feeding artery and central vein);
✓. With hemodynamically significant AVF/AVG stenosis and meeting two of the following conditions (A \& B) A. ≥ 50% stenosis of the target lesion as assessed by angiography B. Presence of at least one of the following (as defined in the NKF-K/DOQI guidelines) 1)Significantly elevated venous pressure during dialysis 2)Unexplained decrease in dialysis dose 3)Decrease in pump-controlled blood flow;
✓. De novo or restenotic target lesion consisting of one or more tandem lesions, and with a visual reference vessel diameter of 4.0-8.0 mm and a total length ≤ 40 mm for the target lesion;
✓. All non-target lesions must have \<50% stenosis without clinical indication for treatment.
✓. Patients who have signed the informed consent form.
Exclusion criteria
✕. Patients who are participating in another clinical trial of a drug product or medical device;
✕. Patients previously enrolled in this trial;
✕. Women of childbearing age with a non-negative pregnancy test prior to surgical procedure, or lactating women;
✕. Patients treated with major surgeries (e.g., open-heart surgery, cranial surgery) within 30 days prior to enrollment in the study;
What they're measuring
1
Target lesion primary patency (TLPP) at 6 months post-procedure
✕. Immature AVF/AVG (not subjected to dialysis; this vascular access has not been subjected to a single successful dialysis due to insufficient inner diameter that prevents successful puncture and results in inadequate blood flow);
✕. Calcified lesions that are not expected to be dilated with a balloon;