Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Ste… (NCT06422845) | Clinical Trial Compass
RecruitingNot Applicable
Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis
China328 participantsStarted 2024-09-30
Plain-language summary
This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous fistula stenosis.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 and ≤ 80 years old;
✓. The patient's AVF/AVG is mature and has successfully completed hemodialysis at least once;
✓. The target lesion is located at the AVF/AVG return vein and venous side anastomosis;
✓. Hemodynamically significant AVF/AVG return vein stenosis ≥ 50% as assessed by ultrasound or contrast imaging, and any of the following clinical symptoms, signs or indicators are present, including significant increase in venous pressure during dialysis, abnormal physical examination, decreased pump-controlled blood flow, decreased adequacy of dialysis, brachial artery blood flow \< 600 ml/min or decreased by 25% compared with the previous follow-up visit, etc.;
✓. The target lesion is a primary or restenotic lesion, consisting of one or more tandem lesions (if the total length of adjacent tandem lesions is ≤ 60 mm, it can be considered a single target lesion);
✓. Visual inspection of the reference blood vessel diameter of the target lesion is between 4.0-8.0mm, and the total length of the target lesion is ≤ 60mm;
✓. The patient voluntarily signs the informed consent form.
Exclusion criteria
✕. Women of childbearing age whose preoperative pregnancy test is not negative, and women who are breastfeeding;
✕. Patients who have undergone major surgical treatment within 30 days before inclusion in the study;
✕. Calcified lesions that are not expected to be expandable with balloons;
What they're measuring
1
Target Lesion Primary Patency (TLPP) at 6 months post-procedure