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

Not Applicable

Withdrawn

• Conditions: Stenosis
• Interventions: Procedure: CUTTING BALLOON ANGIOPLASTY; Procedure: Balloon angioplasty

• Registration Number: NCT00543348
• Lead Sponsor: Henry Ford Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-11
• Study First Submitted QC: 2007-10-11
• Study First Posted: 2007-10-12
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• Arteriovenous prosthetic grafts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CUTTING BALLOON ANGIOPLASTY	CUTTING BALLOON ANGIOPLASTY
2	Balloon angioplasty	Balloon angioplasty with a high pressure balloon
2	CUTTING BALLOON ANGIOPLASTY	Balloon angioplasty with a high pressure balloon

Primary Outcome Measures

Name	Time	Method
Primary and assisted patency	6 months

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States