Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access

Study Overview
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Brief Summary
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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.

Detailed Description
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Although wrist radiocephalic arteriovenous fistula (RCAVF) has been recommended as first preferred fistula in many clinical practical guidelines for vascular access, there are no randomized controlled trials (RCTs) comparing the recommended anatomic order of distal-to-proximal access construction up to now. A modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) that has a long length of suitable superficial vein for cannulation and a sufficient blood flow for effective dialysis has been introduced by investigator for several years. In addition, mNT-BBAVF has good primary patency and a low risk of complication and leave opportunities for further procedures in the event of failure. 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.

Official Title
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A Multicenter, Open-labelled, Randomized Study to Compare the Primary Patency and Safety of Elbow Modified Non-transposed Brachiobasilic Arteriovenous Fistula With Wrist Radiocephalic Arteriovenous Fistula in Hemodialysis Patients

Conditions
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End Stage Renal Disease on Dialysis

Intervention / Treatment
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* Procedure: mNT-BBAVF
* Procedure: RCAVF


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mNT-BBAVF<br>These patients will receive a modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) at elbow for hemodialysis acess. | Procedure: mNT-BBAVF<br>* Briefly, to construct an mNT-BBAVF, an incision is made on the ulnar side of the elbow. The brachial artery and basilic vein are then isolated, and a side-to-side anastomosis is performed without transposition of the basilic vein.<br>|
| Active Comparator: RCAVF<br>These patients will receive a radiocephalic arteriovenous fistula (RCAVF) at wrist for hemodialysis acess. | Procedure: RCAVF<br>* Briefly, to construct a wrist RCAVF, an incision is made on the radial side of the wrist. The radial artery and cephalic vein are then isolated, and a end-to-side anastomosis is performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Unassisted Patency | This is the time of access creation or placement until any first intervention to maintain or restore blood flow | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate Vascular Access Failure | This is an access that has either no appearance of or a loss of bruit or thrill within 72 hours of creation | 72 hours | 
| Cumulative Patency | This is the time of access creation or placement until access abandonment | 1 year | 
| Early Dialysis Suitability Failure | This is an access that, despite radiological or surgical intervention, cannot be used successfully for dialysis by the third month following its creation. | 3 months |