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

This study is not yet open for participant recruitment.
Verified February 2012 by N.M.B. Medical Applications Ltd
Sponsor:
Information provided by (Responsible Party):
N.M.B. Medical Applications Ltd
ClinicalTrials.gov Identifier:
NCT01538108
First received: February 15, 2012
Last updated: February 22, 2012
Last verified: February 2012
History of Changes
  Purpose

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:

Drug Information available for: Paclitaxel
U.S. FDA Resources

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)
PBA

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538108

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

Locations
Israel
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

No publications provided

Responsible Party: N.M.B. Medical Applications Ltd
ClinicalTrials.gov 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:
Arteriovenous Fistula
Fistula
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
 Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013