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

Primary Purpose

Obstructive Lesions of Arteriovenous Dialysis Fistulae

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
PTA Balloon catheter with paclitaxel
Plain Balloon angioplasty (PBA)
Sponsored by
N.M.B. Medical Applications Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Lesions of Arteriovenous Dialysis Fistulae

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Chaim Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NMB's PTA Balloon catheter with paclitaxel

Standard Angioplasty Balloon

Arm Description

Outcomes

Primary Outcome Measures

Restenosis Rate

Secondary Outcome Measures

Restenosis rate
Easy insertion and removal
Major adverse events

Full Information

First Posted
February 15, 2012
Last Updated
February 22, 2012
Sponsor
N.M.B. Medical Applications Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01538108
Brief Title
Study of NMB (Company's Name) Drug Ejecting Balloon for Arteriovenous Fistulae
Official Title
The Use of NMB Drug Ejecting Balloon for Arteriovenous (AV) Dialysis Fistulae
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
N.M.B. Medical Applications Ltd

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Lesions of Arteriovenous Dialysis Fistulae

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NMB's PTA Balloon catheter with paclitaxel
Arm Type
Experimental
Arm Title
Standard Angioplasty Balloon
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
PTA Balloon catheter with paclitaxel
Intervention Description
patients treated by the NMB's PTA Balloon catheter with paclitaxel
Intervention Type
Procedure
Intervention Name(s)
Plain Balloon angioplasty (PBA)
Intervention Description
PBA
Primary Outcome Measure Information:
Title
Restenosis Rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Restenosis rate
Time Frame
1,3 and 12 months
Title
Easy insertion and removal
Time Frame
intraprocedural
Title
Major adverse events
Time Frame
intraprocedural, 1, 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uri Rimon, MD
Phone
972-3-5302530
Email
Uri.Rimon@sheba.health.gov.il
Facility Information:
Facility Name
The Chaim Sheba Medical Center
City
Tel Hashomer
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uri Rimon, MD
Phone
972-3-5302530

12. IPD Sharing Statement

Learn more about this trial

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

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