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Clinical Trials/NCT01538108
NCT01538108UnknownNot Applicable

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

N.M.B. Medical Applications Ltd1 site in 1 country40 target enrollmentStarted: July 1, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Restenosis Rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Restenosis Rate

Time Frame: 6 months

Secondary Outcomes

  • Restenosis rate(1,3 and 12 months)
  • Easy insertion and removal(intraprocedural)
  • Major adverse events(intraprocedural, 1, 3, 6 and 12 months)

Investigators

Sponsor
N.M.B. Medical Applications Ltd
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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