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

NCT ID: NCT00543348

Last Updated: 2022-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

CUTTING BALLOON ANGIOPLASTY

Group Type ACTIVE_COMPARATOR

CUTTING BALLOON ANGIOPLASTY

Intervention Type PROCEDURE

CUTTING BALLOON

2

Balloon angioplasty with a high pressure balloon

Group Type PLACEBO_COMPARATOR

CUTTING BALLOON ANGIOPLASTY

Intervention Type PROCEDURE

CUTTING BALLOON

Balloon angioplasty

Intervention Type PROCEDURE

HIGH PRESSURE BALLOON

Interventions

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CUTTING BALLOON ANGIOPLASTY

CUTTING BALLOON

Intervention Type PROCEDURE

Balloon angioplasty

HIGH PRESSURE BALLOON

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Arteriovenous prosthetic grafts
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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loay kabbani, MD

Vascular Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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GEORGES HADDAD, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

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Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HFHIRB4244

Identifier Type: -

Identifier Source: org_study_id

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