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

Henry Ford Health System

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Stenosis

Interventions

CUTTING BALLOON ANGIOPLASTYPROCEDURE

CUTTING BALLOON

Balloon angioplastyPROCEDURE

HIGH PRESSURE BALLOON

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Dysfunctional fistulas will be recruited based on the presence of clinical and hemodialysis parameters Exclusion Criteria: * Arteriovenous prosthetic grafts

Locations (1)

Henry Ford Hospital

Detroit, Michigan, United States

Outcomes

Primary Outcomes

Primary and assisted patency

Time frame: 6 months

Data from ClinicalTrials.gov

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