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

NCT ID: NCT01538108

Last Updated: 2012-02-23

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-07-31

Brief Summary

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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

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Conditions

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Obstructive Lesions of Arteriovenous Dialysis Fistulae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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NMB's PTA Balloon catheter with paclitaxel

Group Type EXPERIMENTAL

PTA Balloon catheter with paclitaxel

Intervention Type DEVICE

patients treated by the NMB's PTA Balloon catheter with paclitaxel

Standard Angioplasty Balloon

Group Type ACTIVE_COMPARATOR

Plain Balloon angioplasty (PBA)

Intervention Type PROCEDURE

PBA

Interventions

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PTA Balloon catheter with paclitaxel

patients treated by the NMB's PTA Balloon catheter with paclitaxel

Intervention Type DEVICE

Plain Balloon angioplasty (PBA)

PBA

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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N.M.B. Medical Applications Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Central Contacts

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Uri Rimon, MD

Role: CONTACT

972-3-5302530

Facility Contacts

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Uri Rimon, MD

Role: primary

972-3-5302530

Other Identifiers

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NMB AVS P

Identifier Type: -

Identifier Source: org_study_id

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