UnknownNot Applicable

Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access

China160 participantsStarted 2019-12-01

Plain-language summary

Investigator plan to conduct a multicenter, open-labelled, randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with chronic kidney disease (CKD) stage 5 requiring hemodialysis (including pre-dialysis patients) and eligible for a native arteriovenous fistula;
✓. Adult (age ≥ 18 years old);
✓. Preoperative Doppler ultrasonography showing target vein diameter(s) ≥ 2.0 mm and target artery diameter(s) ≥ 2.0 mm;
✓. Estimated life expectancy \> 1 year;
✓. Written informed consent obtained;
✓. Patient is free of clinically significant conditions or illness that may compromise the procedure within 30 days prior to AVF creation

Exclusion criteria

✕. Patients with a history of cerebral hemorrhage or gastrointestinal hemorrhage are excluded from the study;
✕. New York Heart Association class III or IV heart failure;
✕. Patients who are absent of median cubital vein and verified by preoperative Doppler ultrasonography are excluded from the study;
✕. Known central venous stenosis, central vein narrowing \> 50% or deep vein thrombosis based on imaging on the same side as the planned AVF creation;
✕. Prior arm surgically created access in the planned treatment arm;
✕. Immunosuppression (i.e. use of immunosuppressive medications to treat an active condition).

What they're measuring

Primary Unassisted Patency

Timeframe: 1 year

Trial details

NCT IDNCT03701243

SponsorShanghai 10th People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-31

Contact for this trial

Changbin Li, MD

+86 13916907936 changbin_li@tongji.edu.cn

View on ClinicalTrials.gov More End Stage Renal Disease on Dialysis trials