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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
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 ]

Secondary Outcome Measures:
  • 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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Additional relevant MeSH terms:
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017