Study of NMB (Company's Name) Drug Ejecting Balloon for Arteriovenous Fistulae

N.M.B. Medical Applications

Status: Unknown

Conditions: Obstructive Lesions of Arteriovenous Dialysis Fistulae

Treatments: Device: PTA Balloon catheter with paclitaxel; Procedure: Plain Balloon angioplasty (PBA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01538108

NMB AVS P

Details and patient eligibility

About

The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) Balloon.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients 18 years and older
• Patients with arteriovenous fistula with obstructive lesion
• Patient who is willing and able to sign a written informed consent

Exclusion criteria

• age < 18
• female with child bearing potential
• Previous participation in another study with any investigational drug or device within the past 30 days
• Life expectancy of less than 12 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

NMB's PTA Balloon catheter with paclitaxel

Experimental group

Treatment:

Device: PTA Balloon catheter with paclitaxel

Standard Angioplasty Balloon

Active Comparator group

Treatment:

Procedure: Plain Balloon angioplasty (PBA)