Drug Eluting Balloon for Prevention of Hemodialysis Access Restenosis (DEB)
Primary Purpose
Arteriovenous Fistulae, Arteriovenous Graft
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Paclitaxel Eluting Balloon Angioplasty
Percutaneous Transluminal Angioplasty (PTA)
Sponsored by
About this trial
This is an interventional treatment trial for Arteriovenous Fistulae focused on measuring arteriovenous fistulae, arteriovenous graft, restenosis, angioplasty, drug eluting balloon
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hôpital Charles-Lemoyne
- Hôpital Maisonneuve-Rosemont
- Centre Hospitalier de l'université de Montréal-CHUM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Paclitaxel Eluting Balloon
Conventional uncoated balloon
Arm Description
Paclitaxel Eluting Balloon Angioplasty
Percutaneous Transluminal Angioplasty (PTA)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Change of HA flow
Difference between mean HA flow in the two groups (measured at the same times)
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
Drug eluting balloon safety
Proportion of patients with side effects in the 2 groups.
Full Information
NCT ID
NCT01928498
First Posted
August 21, 2013
Last Updated
January 18, 2021
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Biotronik Canada Inc
1. Study Identification
Unique Protocol Identification Number
NCT01928498
Brief Title
Drug Eluting Balloon for Prevention of Hemodialysis Access Restenosis
Acronym
DEB
Official Title
Evaluation of Drug Eluting Balloon for the Prevention of Hemodialysis Access Restenosis: A Prospective Randomized Trial (DEB Study)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
January 13, 2020 (Actual)
Study Completion Date
August 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Biotronik Canada Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriovenous Fistulae, Arteriovenous Graft
Keywords
arteriovenous fistulae, arteriovenous graft, restenosis, angioplasty, drug eluting balloon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel Eluting Balloon
Arm Type
Experimental
Arm Description
Paclitaxel Eluting Balloon Angioplasty
Arm Title
Conventional uncoated balloon
Arm Type
Active Comparator
Arm Description
Percutaneous Transluminal Angioplasty (PTA)
Intervention Type
Device
Intervention Name(s)
Paclitaxel Eluting Balloon Angioplasty
Other Intervention Name(s)
Passeo-18 Lux
Intervention Type
Device
Intervention Name(s)
Percutaneous Transluminal Angioplasty (PTA)
Other Intervention Name(s)
Passeo-18
Primary Outcome Measure Information:
Title
Late lumen loss (LLL) at 6 months after PTA (percutaneous transluminal angioplasty)
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The angiographic percentage of diameter stenosis and the incidence of angiographic binary restenosis rate (≥50% of the diameter of the reference-vessel segment)
Description
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.
Time Frame
6 months
Title
Change of HA flow
Description
Difference between mean HA flow in the two groups (measured at the same times)
Time Frame
Before angioplasty, week 1, month 1or month 3
Title
The rate of HA failure
Description
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
Time Frame
3 months
Title
Drug eluting balloon safety
Description
Proportion of patients with side effects in the 2 groups.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Éric Therasse, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Charles-Lemoyne
City
Longueuil
State/Province
Quebec
Country
Canada
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Centre Hospitalier de l'université de Montréal-CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
12. IPD Sharing Statement
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Drug Eluting Balloon for Prevention of Hemodialysis Access Restenosis
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