Obstructive Lesions of Arteriovenous Dialysis FistulaeNCT01538108
Study of NMB (Company's Name) Drug Ejecting Balloon for Arteriovenous Fistulae
A study testing PTA Balloon catheter with paclitaxel and Plain Balloon angioplasty (PBA) 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) Balloon. 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?
- PTA Balloon catheter with paclitaxel and Plain Balloon angioplasty (PBA)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2012to Jul 2014
- 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
- patients 18 years and older
- Patients with arteriovenous fistula with obstructive lesion
- Patient who is willing and able to sign a written informed consent
Who cannot join
- age < 18
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
The Chaim Sheba Medical Center
Tel HaShomer
Uri Rimon, MD, 972-3-5302530
About this study
Official title: The Use of NMB Drug Ejecting Balloon for Arteriovenous (AV) Dialysis Fistulae
The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) Balloon.
- Being tested
- PTA Balloon catheter with paclitaxel, Plain Balloon angioplasty (PBA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTA Balloon catheter with paclitaxelDevice
patients treated by the NMB's PTA Balloon catheter with paclitaxel
Plain Balloon angioplasty (PBA)Procedure or surgery
PBA
| Study group | Role | What they receive |
|---|---|---|
| NMB's PTA Balloon catheter with paclitaxel | Experimental | Not described Receives: Device: PTA Balloon catheter with paclitaxel |
| Standard Angioplasty Balloon | Active comparator | Not described Receives: Procedure: Plain Balloon angioplasty (PBA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restenosis Rate
Measured: 6 months
Secondary outcomes (3)
Restenosis rate
Measured: 1,3 and 12 months
Easy insertion and removal
Measured: intraprocedural
Major adverse events
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 posted23 Feb 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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
- NCT01538108
- Sponsor's protocol ID
- NMB AVS P
- Status last verified
- Feb 2012
- First submitted
- 15 Feb 2012
- Last updated
- 23 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of NMB Drug Ejecting Balloon for Arteriovenous (AV) Dialysis Fistulae
- ClinicalTrials.gov ID
- NCT01538108
- Acronym / sponsor ID
- NMB AVS P
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- N.M.B. Medical Applications LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 23 Feb 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) Balloon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMB's PTA Balloon catheter with paclitaxel | Experimental | Device: PTA Balloon catheter with paclitaxel |
| Standard Angioplasty Balloon | Active comparator | Procedure: Plain Balloon angioplasty (PBA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients 18 years and older
- Patients with arteriovenous fistula with obstructive lesion
- Patient who is willing and able to sign a written informed consent
Key exclusion criteria (4 listed)
- age < 18
- 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
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 |
|---|---|---|
| PTA Balloon catheter with paclitaxelpatients treated by the NMB's PTA Balloon catheter with paclitaxel | Device | NMB's PTA Balloon catheter with paclitaxel |
| Plain Balloon angioplasty (PBA)PBA | Procedure or surgery | Standard Angioplasty Balloon |
Primary outcome
Restenosis Rate
Time frame: 6 months
3 secondary outcomes
Restenosis rate
Time frame: 1,3 and 12 months
Easy insertion and removal
Time frame: intraprocedural
Major adverse events
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 23 Feb 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 PTA Balloon catheter with paclitaxel and Plain Balloon angioplasty (PBA) 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 3 inclusion and 4 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 23 Feb 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 Uri Rimon, MD (972-3-5302530, Uri.Rimon@sheba.health.gov.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 23 Feb 2012.