To determine whether repair of asymptomatic stenosis in arteriovenous fistula for hemodialysis can improve vascular access survival

To determine whether repair of asymptomatic stenosis in arteriovenous fistula for hemodialysis can improve vascular access survival: an open randomized comparative interventional trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN69115386

Enrollment

Registered

2013-01-31

Start date

2006-10-01

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic AVF stenosis Circulatory System Coronary arteriovenous fistula, acquired

Interventions

In the control group, stenosis will be corrected in response to access dysfunction or a Qa25% drop in Qa. These Qa criteria were choosen because of their high sensitivity to detect stenosis in AVF in

1:448). In both groups, thrombectomy was performed depending on the availability of the attending radiologist and vascular surgeon by manual catheter-directed thrombo-aspiration or su

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >18 years old, either sex 2. Hemodialysis patients with arteriovenous mature AVF with angiographically-proven significant (>50% reduction in vessel diameter) asymptomatic stenosis (i.e. in a well-functioning access capable of delivering a spKt/V >1.2 within a 4-hour period and no dialysis-related abnormalities) and a Qa >500 ml/min. 3. Able to provide informed consent

Exclusion criteria

Exclusion criteria: Any endovascular or surgical intervention in the 3 months prior to enrolment

Design outcomes

Primary

Measure	Time frame
1. Access failure, the composite of thrombosis or pre-emptive intervention triggered by signs of impending thrombosis (a Qa60 ml/min drop of the prescribed Qb) (Tessitore et al., AJKD 2003, 42:331) 2. Access abandonment, because patency could not be restored after a thrombotic episode (because the access was considered unsalvageable or thrombectomy was unsuccessful), or a patent access was unsuitable for cannulation or unable to sustain adequate dialysis (i.e. a spKt/V<1.0 within a 4-hour hemodialysis session)	—

Measure

Time frame

1. Access failure, the composite of thrombosis or pre-emptive intervention triggered by signs of impending thrombosis (a Qa60 ml/min drop of the prescribed Qb) (Tessitore et al., AJKD 2003, 42:331) 2. Access abandonment, because patency could not be restored after a thrombotic episode (because the access was considered unsalvageable or thrombectomy was unsuccessful), or a patent access was unsuitable for cannulation or unable to sustain adequate dialysis (i.e. a spKt/V<1.0 within a 4-hour hemodialysis session)

—

Secondary

Measure	Time frame
Direct cost of access treatment, including all expenses for surveillance and imaging during the follow-up, elective endovascular and surgical intervention, thrombectomy, placement of a new access or a cuffed and uncuffed temporary central venous catheter, and hospitalization.	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026