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

Henry Ford Health

Status: Withdrawn

Conditions: Stenosis

Treatments: Procedure: CUTTING BALLOON ANGIOPLASTY; Procedure: Balloon angioplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00543348

HFHIRB4244

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Arteriovenous prosthetic grafts

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

CUTTING BALLOON ANGIOPLASTY

Treatment:

Procedure: CUTTING BALLOON ANGIOPLASTY

2

Placebo Comparator group

Description:

Balloon angioplasty with a high pressure balloon

Treatment:

Procedure: Balloon angioplasty

Procedure: CUTTING BALLOON ANGIOPLASTY