RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses

A Randomised-Controlled Study Comparing the Peripheral Cutting BalloonTM (Boston Scientific Co.) With a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00543348

Enrollment

Registered

2007-10-12

Start date

2007-09-30

Completion date

2008-03-31

Last updated

2022-03-21

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

Conditions

Stenosis

Keywords

BALLOON ANGIOPLASTY, AUTOGENOUS FISTULA

Brief summary

The proposed study will investigate the efficacy of the peripheral cutting balloon (PBC) compared to the high pressure balloon in dilating venous stenosis in hemodialysis fistulas. 2\. SPECIFIC AIMS Study endpoints will be: Primary Endpoint 1\. Primary and assisted patency at 6 months Secondary Endpoints: 1. Procedure effectiveness/residual stenosis 2. Procedure-related complications 3. Primary patency and primary assisted patency 12 months 4. Secondary patency at 6 and 12 months 5. Number/type of secondary interventions.

Interventions

PROCEDURECUTTING BALLOON ANGIOPLASTY

CUTTING BALLOON

PROCEDUREBalloon angioplasty

HIGH PRESSURE BALLOON

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Dysfunctional fistulas will be recruited based on the presence of clinical and hemodialysis parameters

Exclusion criteria

* Arteriovenous prosthetic grafts

Design outcomes

Primary

Measure	Time frame
Primary and assisted patency	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026