Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae
NCT ID: NCT01646788
Last Updated: 2012-07-24
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
10 participants
INTERVENTIONAL
2013-01-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental
NMB's PTA Balloon catheter with Paclitaxel drug
NMB Paclitaxel Drug Ejecting Balloon
NMB's PTA Balloon catheter with drug
Interventions
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NMB Paclitaxel Drug Ejecting Balloon
NMB's PTA Balloon catheter with drug
Eligibility Criteria
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Inclusion Criteria
2. Native arteriovenous fistula or synthetic arteriovenous access graft performed/implanted more than 45 days before enrollment and at least one successful hemodialysis session performed.
3. Patient having obstructive lesion of native or synthetic arteriovenous dialysis fistulae/grafts, suitable for PTA procedure.
4. Patient who is willing and able to sign a written informed consent and that complies with procedures (including adherence to follow-up visits).
Exclusion Criteria
2. Previous participation in another study with any investigational drug or device within the past 30 days.
3. Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult.
4. Known hypersensitivity to paclitaxel or structurally-related compounds.
5. Severe reaction to contrast agents that cannot be adequately premedicated prior to procedure.
6. Stenosis with corresponding thrombosis treated within 7 days before enrollment.
7. Patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy.
8. Infected grafts/fistulae.
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 Rabin Medical Center, Hasharon Hospital
Petah Tikva, , Israel
Countries
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Central Contacts
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Other Identifiers
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NMB AVS HSR
Identifier Type: -
Identifier Source: org_study_id