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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by N.M.B. Medical Applications Ltd.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
N.M.B. Medical Applications Ltd Identifier:
First received: February 15, 2012
Last updated: February 22, 2012
Last verified: February 2012
The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) Balloon.

Condition Intervention
Obstructive Lesions of Arteriovenous Dialysis Fistulae
Device: PTA Balloon catheter with paclitaxel
Procedure: Plain Balloon angioplasty (PBA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Use of NMB Drug Ejecting Balloon for Arteriovenous (AV) Dialysis Fistulae

Resource links provided by NLM:

Further study details as provided by N.M.B. Medical Applications Ltd:

Primary Outcome Measures:
  • Restenosis Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Restenosis rate [ Time Frame: 1,3 and 12 months ] [ Designated as safety issue: No ]
  • Easy insertion and removal [ Time Frame: intraprocedural ] [ Designated as safety issue: Yes ]
  • Major adverse events [ Time Frame: intraprocedural, 1, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NMB's PTA Balloon catheter with paclitaxel Device: PTA Balloon catheter with paclitaxel
patients treated by the NMB's PTA Balloon catheter with paclitaxel
Active Comparator: Standard Angioplasty Balloon Procedure: Plain Balloon angioplasty (PBA)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01538108

Contact: Uri Rimon, MD 972-3-5302530

The Chaim Sheba Medical Center Not yet recruiting
Tel Hashomer, Israel
Contact: Uri Rimon, MD    972-3-5302530      
Sponsors and Collaborators
N.M.B. Medical Applications Ltd
  More Information

Responsible Party: N.M.B. Medical Applications Ltd Identifier: NCT01538108     History of Changes
Other Study ID Numbers: NMB AVS P 
Study First Received: February 15, 2012
Last Updated: February 22, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators processed this record on May 26, 2016