Arteriovenous FistulaeDEBNCT01928498
Drug Eluting Balloon for Prevention of Hemodialysis Access Restenosis
A study testing Paclitaxel Eluting Balloon Angioplasty and Percutaneous Transluminal Angioplasty (PTA) in people with Arteriovenous Fistulae and Arteriovenous Graft, run by Centre hospitalier de l'Université de Montréal (CHUM) at 3 sites in Canada.
Trial summary
The purpose of this study is to evaluate the effectiveness of paclitaxel-coated balloon catheter to prevent restenosis after PTA (percutaneous transluminal angioplasty) of hemodialysis access (HA) in comparison with the uncoated PTA balloon catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistulae, Arteriovenous Graft
- What is being tested?
- Paclitaxel Eluting Balloon Angioplasty and Percutaneous Transluminal Angioplasty (PTA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2013to 27 Aug 2020
- 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
- Clinical or hemodynamic evidence of HA dysfunction according to the clinician's judgment
- Patients with AVF (arteriovenous fistulae)or AVG (arteriovenous graft) located in the forearm or upper arm and is > 3 months old
- Minimum age of 18 years and written informed consent
- Target lesion stenosis is <3.0 cm in length and >50% in luminal diameter reduction
- Maximum of two secondary lesions (stenoses) if the following criteria are satisfied: The secondary lesion is located in the graft or peripheral veins, the secondary lesion is <3.0 cm in length and located >1.0 cm away from the target lesion, the secondary lesion is >50% luminal reduction compared to the reference vessel diameter
- Reference vessel diameter between 4 to 7 mm
Show all 9Show fewer
- The HA must not be thrombosed and the lesion can be crossed with guide wire before angioplasty
- Lesion site: from 2 cm above the arterial anastomosis to the superior vena cava
- Restenotic lesion (previously treated by PTA or stent) or de novo lesion
Who cannot join
- Contraindication to angiography or PTA
- Intervention of the HA circuit within the past 30 days
- Systemic infection or a local infection associated with the graft
- The patient is pregnant
- Patient is enrolled in another investigational study.
- Life expectancy < 12 months
- History of severe allergic reaction to contrast media or to paclitaxel
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Hôpital Charles-Lemoyne
Longueuil, Quebec
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Centre Hospitalier de l'université de Montréal-CHUM
Montreal, Quebec, H2L 4M1
About this study
Official title: Evaluation of Drug Eluting Balloon for the Prevention of Hemodialysis Access Restenosis: A Prospective Randomized Trial (DEB Study)
The purpose of this study is to evaluate the effectiveness of paclitaxel-coated balloon catheter to prevent restenosis after PTA (percutaneous transluminal angioplasty) of hemodialysis access (HA) in comparison with the uncoated PTA balloon catheter.
Read the detailed description
In Canada, there are over 20,000 patients with chronic end-stage renal disease (ESRD)on long-term hemodialysis and the number is increasing rapidly.The creation of hemodialysis access (HA) (also called "lifeline" for dialysis patients) has become the most common type of vascular surgery. These HA are frequently complicated by dysfunction after their creation mainly due to neointimal hyperplastic stenosis (> 60% at one year). PTA is an established cornerstone method of treating stenotic lesions because of its minimally invasive percutaneous nature and widespread availability.Although PTA has a high initial success rate,narrowing will often recur in 2-3 months hence requiring further interventions. There are currently no durable therapies for the prevention or treatment of HA dysfunction restenosis after PTA.
Recently drug eluting balloon (DEB) with paclitaxel have repeatedly demonstrated their effectiveness to prevent restenosis due to intimal proliferation in the coronary and peripheral arterial systems. The investigators believe that the DEB with paclitaxel will significantly decrease the HA restenosis rate at the treated site and therefore will improve the management of HA failures.
- Conditions
- Arteriovenous Fistulae, Arteriovenous Graft
- Being tested
- Paclitaxel Eluting Balloon Angioplasty, Percutaneous Transluminal Angioplasty (PTA)
- Keywords
- arteriovenous fistulae, arteriovenous graft, restenosis, angioplasty, drug eluting balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Eluting Balloon AngioplastyDevice
Also called Passeo-18 Lux
Percutaneous Transluminal Angioplasty (PTA)Device
Also called Passeo-18
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel Eluting Balloon | Experimental | Paclitaxel Eluting Balloon Angioplasty Receives: Device: Paclitaxel Eluting Balloon Angioplasty |
| Conventional uncoated balloon | Active comparator | Percutaneous Transluminal Angioplasty (PTA) Receives: Device: Percutaneous Transluminal Angioplasty (PTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late lumen loss (LLL) at 6 months after PTA (percutaneous transluminal angioplasty)
Comparison of the mean LLL (late lumen loss) in patients in the two trial arms (DEB vs plain PTA) evaluated by quantitative angiography at six months after PTA.
LLL is defined as the difference between the MLD (minimum lumen diameter) immediately after balloon angioplasty and the MLD at follow-up
Measured: 6 months
Secondary outcomes (4)
The angiographic percentage of diameter stenosis and the incidence of angiographic binary restenosis rate (≥50% of the diameter of the reference-vessel segment)
The change in the degree of stenosis (in %) at the intervention site between the measure right after the intervention, and 6 months later and the difference between restenosis rates in the two trial arms at 6 months.
Measured: 6 months
Change of HA flow
Difference between mean HA flow in the two groups (measured at the same times)
Measured: Before angioplasty, week 1, month 1or month 3
The rate of HA failure
Time elapsed from the initial intervention (at randomization) to the earliest (if any) of these 3 events: HA thrombosis, HA re-intervention (surgical or endovascular, including creation of a new HA), or CVC (central venous catheter) insertion for dialysis purpose
Measured: 3 months
Drug eluting balloon safety
Proportion of patients with side effects in the 2 groups.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2013 (estimated)
- Study startOct 2013
- Primary completion13 Jan 2020
- Study completion27 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulaeStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik Canada Inc
- Responsible party
- Sponsor
- Investigators
- Éric Therasse, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928498
- Sponsor's protocol ID
- CE13.093 (2014-5032)
- Acronym
- DEB
- Status last verified
- Jan 2021
- First submitted
- 21 Aug 2013
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Drug Eluting Balloon for the Prevention of Hemodialysis Access Restenosis: A Prospective Randomized Trial (DEB Study)
- ClinicalTrials.gov ID
- NCT01928498
- Acronym / sponsor ID
- DEB / CE13.093 (2014-5032)
- Conditions
- Arteriovenous Fistulae, Arteriovenous Graft
- Keywords
- arteriovenous fistulae, arteriovenous graft, restenosis, angioplasty, drug eluting balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Biotronik Canada Inc
- Study start
- Oct 2013 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 26 Aug 2013 (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 evaluate the effectiveness of paclitaxel-coated balloon catheter to prevent restenosis after PTA (percutaneous transluminal angioplasty) of hemodialysis access (HA) in comparison with the uncoated PTA balloon catheter.
Detailed description
In Canada, there are over 20,000 patients with chronic end-stage renal disease (ESRD)on long-term hemodialysis and the number is increasing rapidly.The creation of hemodialysis access (HA) (also called "lifeline" for dialysis patients) has become the most common type of vascular surgery. These HA are frequently complicated by dysfunction after their creation mainly due to neointimal hyperplastic stenosis (> 60% at one year). PTA is an established cornerstone method of treating stenotic lesions because of its minimally invasive percutaneous nature and widespread availability.Although PTA has a high initial success rate,narrowing will often recur in 2-3 months hence requiring further interventions. There are currently no durable therapies for the prevention or treatment of HA dysfunction restenosis after PTA.
Recently drug eluting balloon (DEB) with paclitaxel have repeatedly demonstrated their effectiveness to prevent restenosis due to intimal proliferation in the coronary and peripheral arterial systems. The investigators believe that the DEB with paclitaxel will significantly decrease the HA restenosis rate at the treated site and therefore will improve the management of HA failures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel Eluting Balloon | Experimental | Device: Paclitaxel Eluting Balloon AngioplastyPaclitaxel Eluting Balloon Angioplasty |
| Conventional uncoated balloon | Active comparator | Device: Percutaneous Transluminal Angioplasty (PTA)Percutaneous Transluminal Angioplasty (PTA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical or hemodynamic evidence of HA dysfunction according to the clinician's judgment
- Patients with AVF (arteriovenous fistulae)or AVG (arteriovenous graft) located in the forearm or upper arm and is > 3 months old
- Minimum age of 18 years and written informed consent
- Target lesion stenosis is <3.0 cm in length and >50% in luminal diameter reduction
- Maximum of two secondary lesions (stenoses) if the following criteria are satisfied: The secondary lesion is located in the graft or peripheral veins, the secondary lesion is <3.0 cm in length and located >1.0 cm away from the target lesion, the secondary lesion is >50% luminal reduction compared to the reference vessel diameter
Key exclusion criteria (7 listed)
- Contraindication to angiography or PTA
- Intervention of the HA circuit within the past 30 days
- Systemic infection or a local infection associated with the graft
- The patient is pregnant
- Patient is enrolled in another investigational study.
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 |
|---|---|---|
| Paclitaxel Eluting Balloon AngioplastyAlso: Passeo-18 Lux | Device | Paclitaxel Eluting Balloon |
| Percutaneous Transluminal Angioplasty (PTA)Also: Passeo-18 | Device | Conventional uncoated balloon |
Primary outcome
Late lumen loss (LLL) at 6 months after PTA (percutaneous transluminal angioplasty)
Time frame: 6 months
Comparison of the mean LLL (late lumen loss) in patients in the two trial arms (DEB vs plain PTA) evaluated by quantitative angiography at six months after PTA. LLL is defined as the difference between the MLD (minimum lumen diameter) immediately after balloon angioplasty and the MLD at follow-up
4 secondary outcomes
The angiographic percentage of diameter stenosis and the incidence of angiographic binary restenosis rate (≥50% of the diameter of the reference-vessel segment)
Time frame: 6 months
Change of HA flow
Time frame: Before angioplasty, week 1, month 1or month 3
The rate of HA failure
Time frame: 3 months
Drug eluting balloon safety
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
Related trials for Arteriovenous Fistulae
RecruitingObservational study
NAIF 2.0 - COGNIFY
Dural Arteriovenous Fistula, Glymphatic System
Not yet recruiting
Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients
End Stage Renal Failure, Hemodialysis, Vascular Access
Active, not recruiting
Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae
Arteriovenous Fistula
Recruiting
Blood Flow Conditions and Sounds in AVFs
End Stage Renal Disease
Recruiting
Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Treatment
Pulsatile Tinnitus
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.
Éric Therasse, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel Eluting Balloon Angioplasty and Percutaneous Transluminal Angioplasty (PTA) in people with Arteriovenous Fistulae and Arteriovenous Graft, run by Centre hospitalier de l'Université de Montréal (CHUM) at 3 sites in Canada.
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 9 inclusion and 7 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: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late lumen loss (LLL) at 6 months after PTA (percutaneous transluminal angioplasty) (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 20 Jan 2021.