Obstructive Lesions of Arteriovenous Dialysis FistulaeNCT01646788
Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae
A study testing NMB Paclitaxel Drug Ejecting Balloon in people with Obstructive Lesions of Arteriovenous Dialysis Fistulae, run by N.M.B. Medical Applications Ltd at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Lesions of Arteriovenous Dialysis Fistulae
- What is being tested?
- NMB Paclitaxel Drug Ejecting Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- NMB Paclitaxel Drug Ejecting Balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMB Paclitaxel Drug Ejecting BalloonDevice
NMB's PTA Balloon catheter with drug
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | NMB's PTA Balloon catheter with Paclitaxel drug Receives: Device: NMB Paclitaxel Drug Ejecting Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
restenosis rate
As defined above in the primary end point
Measured: 1, 3 and 12 months
Easy insertion and removal
Measured: intraprocedural
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
Measured: intraprocedural 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Lesions of Arteriovenous Dialysis FistulaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.M.B. Medical Applications Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646788
- Sponsor's protocol ID
- NMB AVS HSR
- Status last verified
- Jul 2012
- First submitted
- 16 Jul 2012
- Last updated
- 24 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of NMB Drug Ejecting Balloon for Arteriovenous Fistulae
- ClinicalTrials.gov ID
- NCT01646788
- Acronym / sponsor ID
- NMB AVS HSR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- N.M.B. Medical Applications LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: NMB Paclitaxel Drug Ejecting BalloonNMB's PTA Balloon catheter with Paclitaxel drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMB Paclitaxel Drug Ejecting BalloonNMB's PTA Balloon catheter with drug | Device | Experimental |
Primary outcome
Restenosis rate
Time frame: 6 months
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
3 secondary outcomes
restenosis rate
Time frame: 1, 3 and 12 months
Easy insertion and removal
Time frame: intraprocedural
Major adverse events rate
Time frame: intraprocedural 1, 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMB Paclitaxel Drug Ejecting Balloon in people with Obstructive Lesions of Arteriovenous Dialysis Fistulae, run by N.M.B. Medical Applications Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eli Atar, MD (972-3-9376389, elia@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restenosis rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2012.