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
186 participants
INTERVENTIONAL
2016-01-31
2019-01-31
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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Experimental
Drug eluting angioplasty balloons
Drug eluting balloons
Control
Non-drug eluting balloons
Non drug eluting balloons
Interventions
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Drug eluting balloons
Non drug eluting balloons
Eligibility Criteria
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Inclusion Criteria
* Fistula has been in use for at least 1 month and is \> 6 weeks old
* Brachiocephalic AV fistula
* Brachiobasilic AV fistula
* Radiocephalic AV fistula (both proximal and distal)
* Participant \>/=18 yrs old
* Index lesion is less then the length of the DEB, and the reference vessel diameter is appropriate for treatment with the size range of DEB (4mm - 8mm diameter)
* Participant is able to give valid informed consent
Exclusion Criteria
* Allergy to Paclitaxel
* Prosthetic grafts
* Long or tandem lesions that cannot be treated with a single DEB
* Thrombosed Arterio-Venous fistulas
* Women who are breastfeeding, pregnant or intending to become pregnant
* Participants of child-bearing age who are unwilling to use a reliable form of contraception for the duration of the study.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
University Hospital Birmingham
OTHER
Responsible Party
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Principal Investigators
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Robert Jones, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital Birmingham NHS Foundation Trust
Locations
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University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Countries
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Central Contacts
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N E Anderson
Role: CONTACT
Facility Contacts
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R G Jones, Dr
Role: primary
Other Identifiers
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RRK5479
Identifier Type: -
Identifier Source: org_study_id
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