Study of NMB (Company's Name) Drug Ejecting Balloon for Arteriovenous Fistulae
NCT ID: NCT01538108
Last Updated: 2012-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2012-07-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NMB's PTA Balloon catheter with paclitaxel
PTA Balloon catheter with paclitaxel
patients treated by the NMB's PTA Balloon catheter with paclitaxel
Standard Angioplasty Balloon
Plain Balloon angioplasty (PBA)
PBA
Interventions
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PTA Balloon catheter with paclitaxel
patients treated by the NMB's PTA Balloon catheter with paclitaxel
Plain Balloon angioplasty (PBA)
PBA
Eligibility Criteria
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Inclusion Criteria
* Patients with arteriovenous fistula with obstructive lesion
* Patient who is willing and able to sign a written informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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N.M.B. Medical Applications Ltd
INDUSTRY
Responsible Party
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Locations
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The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Countries
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Central Contacts
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Facility Contacts
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Uri Rimon, MD
Role: primary
Other Identifiers
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NMB AVS P
Identifier Type: -
Identifier Source: org_study_id
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