Back to resultsStudy of NMB Drug Ejecting Balloon for Arteriovenous Fistulae
Primary Purpose
Obstructive Lesions of Arteriovenous Dialysis Fistulae
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
NMB Paclitaxel Drug Ejecting Balloon
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Lesions of Arteriovenous Dialysis Fistulae
Eligibility Criteria
Inclusion Criteria:
- Patient is 18 years old or older.
- Native arteriovenous fistula or synthetic arteriovenous access graft performed/implanted more than 45 days before enrollment and at least one successful hemodialysis session performed.
- Patient having obstructive lesion of native or synthetic arteriovenous dialysis fistulae/grafts, suitable for PTA procedure.
- 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:
- Women who are pregnant or breast-feeding and women of childbearing potential who do not use adequate contraception.
- Previous participation in another study with any investigational drug or device within the past 30 days.
- Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult.
- Known hypersensitivity to paclitaxel or structurally-related compounds.
- Severe reaction to contrast agents that cannot be adequately premedicated prior to procedure.
- Stenosis with corresponding thrombosis treated within 7 days before enrollment.
- Patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy.
- Infected grafts/fistulae.
Sites / Locations
- The Rabin Medical Center, Hasharon Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
NMB's PTA Balloon catheter with Paclitaxel drug
Outcomes
Primary Outcome Measures
Restenosis rate
Binary Stenosis is defined as ≥50% narrowing in luminal diameter basen upon comparison with the adjacent normal vessel.
Restenosis Rate - comparison shall be performed both to the patient previous data as well as to restenosis rate data published in the literature for standard PTA balloon catheter procedure
Secondary Outcome Measures
restenosis rate
As defined above in the primary end point
Easy insertion and removal
Major adverse events rate
All adverse events will be reviewed by the Investigator and evaluated as follows:
Nature of the event.
Severity of the event - serious, moderate, mild.
Relation of the adverse event to the device - unrelated, possible, definite
Full Information
NCT ID
NCT01646788
First Posted
July 16, 2012
Last Updated
July 22, 2012
Sponsor
N.M.B. Medical Applications Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01646788
Brief Title
Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
N.M.B. Medical Applications Ltd
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) for the treatment of obstructive lesions of Arteriovenous (AV) Dialysis Fistulae/Grafts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Lesions of Arteriovenous Dialysis Fistulae
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
NMB's PTA Balloon catheter with Paclitaxel drug
Intervention Type
Device
Intervention Name(s)
NMB Paclitaxel Drug Ejecting Balloon
Intervention Description
NMB's PTA Balloon catheter with drug
Primary Outcome Measure Information:
Title
Restenosis rate
Description
Binary Stenosis is defined as ≥50% narrowing in luminal diameter basen upon comparison with the adjacent normal vessel.
Restenosis Rate - comparison shall be performed both to the patient previous data as well as to restenosis rate data published in the literature for standard PTA balloon catheter procedure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
restenosis rate
Description
As defined above in the primary end point
Time Frame
1, 3 and 12 months
Title
Easy insertion and removal
Time Frame
intraprocedural
Title
Major adverse events rate
Description
All adverse events will be reviewed by the Investigator and evaluated as follows:
Nature of the event.
Severity of the event - serious, moderate, mild.
Relation of the adverse event to the device - unrelated, possible, definite
Time Frame
intraprocedural 1, 3, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is 18 years old or older.
Native arteriovenous fistula or synthetic arteriovenous access graft performed/implanted more than 45 days before enrollment and at least one successful hemodialysis session performed.
Patient having obstructive lesion of native or synthetic arteriovenous dialysis fistulae/grafts, suitable for PTA procedure.
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:
Women who are pregnant or breast-feeding and women of childbearing potential who do not use adequate contraception.
Previous participation in another study with any investigational drug or device within the past 30 days.
Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult.
Known hypersensitivity to paclitaxel or structurally-related compounds.
Severe reaction to contrast agents that cannot be adequately premedicated prior to procedure.
Stenosis with corresponding thrombosis treated within 7 days before enrollment.
Patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy.
Infected grafts/fistulae.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eli Atar, MD
Phone
972-3-9376389
Email
elia@clalit.org.il
Facility Information:
Facility Name
The Rabin Medical Center, Hasharon Hospital
City
Petah Tikva
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae
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