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

Not Applicable

• Conditions: Obstructive Lesions of Arteriovenous Dialysis Fistulae
• Interventions: Device: PTA Balloon catheter with paclitaxel; Procedure: Plain Balloon angioplasty (PBA)

• Registration Number: NCT01538108
• Lead Sponsor: N.M.B. Medical Applications Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-02
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-22
• Last Update Submitted: 2012-02-22
• Study First Posted: 2012-02-23
• Last Update Posted: 2012-02-23
• Study Start: 2012-07
• Primary Completion: 2014-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMB's PTA Balloon catheter with paclitaxel	PTA Balloon catheter with paclitaxel	-
Standard Angioplasty Balloon	Plain Balloon angioplasty (PBA)	-

Primary Outcome Measures

Name	Time	Method
Restenosis Rate	6 months

Secondary Outcome Measures

Name	Time	Method
Restenosis rate	1,3 and 12 months
Easy insertion and removal	intraprocedural
Major adverse events	intraprocedural, 1, 3, 6 and 12 months

Trial Locations

Locations (1)

The Chaim Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel