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

The Use of NMB Drug Ejecting Balloon for Arteriovenous (AV) Dialysis Fistulae

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01538108

Enrollment

Registered

2012-02-23

Start date

2012-07-31

Completion date

2014-07-31

Last updated

2012-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Lesions of Arteriovenous Dialysis Fistulae

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.

Interventions

DEVICEPTA Balloon catheter with paclitaxel

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

PROCEDUREPlain Balloon angioplasty (PBA)

PBA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Restenosis Rate	6 months

Secondary

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

Countries

Israel

Contacts

Primary ContactUri Rimon, MD

Uri.Rimon@sheba.health.gov.il972-3-5302530

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026