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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01538108
Recruitment Status : Unknown
Verified February 2012 by N.M.B. Medical Applications Ltd.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2012
Last Update Posted : February 23, 2012
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Use of NMB Drug Ejecting Balloon for Arteriovenous (AV) Dialysis Fistulae
Study Start Date : July 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty Fistulas
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :
  1. Restenosis Rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Restenosis rate [ Time Frame: 1,3 and 12 months ]
  2. Easy insertion and removal [ Time Frame: intraprocedural ]
  3. Major adverse events [ Time Frame: intraprocedural, 1, 3, 6 and 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538108

Contact: Uri Rimon, MD 972-3-5302530 Uri.Rimon@sheba.health.gov.il

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
ClinicalTrials.gov Identifier: NCT01538108     History of Changes
Other Study ID Numbers: NMB AVS P
First Posted: February 23, 2012    Key Record Dates
Last Update Posted: February 23, 2012
Last Verified: February 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