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

N.M.B. Medical Applications Ltd40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obstructive Lesions of Arteriovenous Dialysis Fistulae

Interventions

PTA Balloon catheter with paclitaxelDEVICE

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

Plain Balloon angioplasty (PBA)PROCEDURE

PBA

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Chaim Sheba Medical Center

Tel Litwinsky, Israel

Outcomes

Primary Outcomes

Restenosis Rate

Time frame: 6 months

Secondary Outcomes

Restenosis rate

Time frame: 1,3 and 12 months

Easy insertion and removal

Time frame: intraprocedural

Major adverse events

Time frame: intraprocedural, 1, 3, 6 and 12 months

Central Contacts

Uri Rimon, MD

CONTACT

972-3-5302530 Uri.Rimon@sheba.health.gov.il

Data from ClinicalTrials.gov

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