Trial Outcomes & Findings for Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas (NCT NCT04376567)

Last Updated: 2025-09-11

Results Overview

Functional clinical patency means the number of participants who were able to use their brachial basilic arteriovenous fistula (BBAVF) successfully for dialysis within 6 months of surgical creation. It refers to using two dialysis needles in at least 75% of dialysis sessions over four weeks without need for additional procedure or surgery, as determined by their providers.

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

6 months

Results posted on

2025-09-11

Participant Flow

Participant milestones

Participant milestones
Measure	One Stage Approach To create a brachial-basilic arteriovenous fistula (BBAVF) using a one-stage approach. The arteriovenous anastomosis is performed and the basilic vein is transposed during the same procedure. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.	Two Stage Approach To create a BBAVF using a two-stage approach, the arteriovenous anastomosis is performed during the first procedure. The superficialization or transposition of the fistula is then performed 6 to 8 weeks later, after the fistula has matured. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	One Stage Approach n=1 Participants To create a brachial-basilic arteriovenous fistula (BBAVF) using a one-stage approach. The arteriovenous anastomosis is performed and the basilic vein is transposed during the same procedure. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.	Two Stage Approach n=1 Participants To create a BBAVF using a two-stage approach, the arteriovenous anastomosis is performed during the first procedure. The superficialization or transposition of the fistula is then performed 6 to 8 weeks later, after the fistula has matured. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Dialysis	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	One Stage Approach n=1 Participants To create a brachial-basilic arteriovenous fistula (BBAVF) using a one-stage approach. The arteriovenous anastomosis is performed and the basilic vein is transposed during the same procedure. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.	Two Stage Approach n=1 Participants To create a BBAVF using a two-stage approach, the arteriovenous anastomosis is performed during the first procedure. The superficialization or transposition of the fistula is then performed 6 to 8 weeks later, after the fistula has matured. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.
Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

Number of participants with dialysis catheter related complications, including infection, procedure to exchange catheter due to malfunction. outcomes of Primary Clinical Functional Patency or CVC-related bacteremia or death

Outcome measures

Outcome measures
Measure	One Stage Approach n=1 Participants To create a brachial-basilic arteriovenous fistula (BBAVF) using a one-stage approach. The arteriovenous anastomosis is performed and the basilic vein is transposed during the same procedure. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.	Two Stage Approach n=1 Participants To create a BBAVF using a two-stage approach, the arteriovenous anastomosis is performed during the first procedure. The superficialization or transposition of the fistula is then performed 6 to 8 weeks later, after the fistula has matured. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.
Number of Participants Who Had Catheter Related Complications	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

Number of participants who had \> 3 months of catheter dependency after arteriovenous fistula creation

Outcome measures

Outcome measures
Measure	One Stage Approach n=1 Participants To create a brachial-basilic arteriovenous fistula (BBAVF) using a one-stage approach. The arteriovenous anastomosis is performed and the basilic vein is transposed during the same procedure. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.	Two Stage Approach n=1 Participants To create a BBAVF using a two-stage approach, the arteriovenous anastomosis is performed during the first procedure. The superficialization or transposition of the fistula is then performed 6 to 8 weeks later, after the fistula has matured. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.
Number of Participants Who Had > 3 Months of Catheter Dependency After Arteriovenous Creation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6-month

Population: Participate did not complete PROMIS questionnaire.

Average quality of life scores assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) for physical function, fatigue, sleep disturbance, and ability to participate in social roles and activities. Data are presented as T-score, which are standardized scores with a mean of 50 and a standard deviation for the reference population (typically the US general population). A T-score of 50 represents the population average. A higher T-score indicates more of the concept being measured and lower T-score indicate less.

Outcome measures

Outcome measures
Measure	One Stage Approach n=1 Participants To create a brachial-basilic arteriovenous fistula (BBAVF) using a one-stage approach. The arteriovenous anastomosis is performed and the basilic vein is transposed during the same procedure. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.	Two Stage Approach To create a BBAVF using a two-stage approach, the arteriovenous anastomosis is performed during the first procedure. The superficialization or transposition of the fistula is then performed 6 to 8 weeks later, after the fistula has matured. One stage approach: Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.
Patient-Reported Outcomes Measurement Information System Scores Over 6 Months Physical function (T-score)	37.5 score on a scale Standard Deviation 33.2	—
Patient-Reported Outcomes Measurement Information System Scores Over 6 Months Fatigue (T-score)	52.3 score on a scale Standard Deviation 61.6	—
Patient-Reported Outcomes Measurement Information System Scores Over 6 Months Sleep disturbance (T-score)	53.6 score on a scale Standard Deviation 39.6	—
Patient-Reported Outcomes Measurement Information System Scores Over 6 Months Ability to participate in social roles and activities (T-score)	44.7 score on a scale Standard Deviation 23.7	—

Adverse Events

One Stage Approach

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Two Stage Approach

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tze-Woei Tan

University of Arizona

Phone: 3234426835

Email: [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place