Back to resultsPaclitaxel-coated Balloon Angioplasty Versus Standard Angioplasty for the Treatment of Stenosis of Arteriovenous Fistula (ABISS)
Primary Purpose
Angioplasty, Stenosis of Arteriovenous Fistula
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Additional angioplasty with paclitaxel-coated balloon
Additional angioplasty with placebo balloon
Conventional angioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Angioplasty focused on measuring Stenosis of arteriovenous fistula, Angioplasty, Paclitaxel-Coated Balloon Angioplasty
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years, man or woman.
- Chronic Hemodialysis.
- Native autologous arteriovenous fistula (AVF).
- AVF used at least once for hemodialysis.
- Preoperative flow measurement of AVF performed by Doppler.
- Length of the stenosis <120 mm.
- Outer diameter of the target vein <12mm.
Hemodynamically significant Stenosis on AV fistula, defined according to international recommendations with the following two criteria:
- stenosis> 50% by Doppler or angiography,
presenting at least one of the following :
- increased venous pressure during dialysis (venous pressure > 150 mmHg when blood flow measured at 200-225 ml / min, or venous pressure > 230 mmHg when blood flow measured at 400 ml / min);
- disappearance of thrill of AV fistula;
- increasing hemostasis time at the end of dialysis (> 20 minutes or increase by >=50% from usual hemostasis time);
- recirculation rate > 20%;
- flow of AVF < 500 ml / min responsible for a reduction of the flow of the dialysis circuit.
- Only one stenosis with significant impact hemodynamically.
- Signed informed consent.
- Patient has a health insurance.
Exclusion Criteria:
- Pregnant or breastfeeding women.
- Severe allergy to iodinated contrast agents, or to heparin, or to paclitaxel.
- Anastomotic stenosis involving the afferent artery.
- Multiple hemodynamically significant stenoses.
- Hemodynamically significant central venous stenosis.
- Stent already in place in treated vascular site.
- Diameter of the vein immediately upstream of stenosis greater than the maximum diameter of active balloon.
- AVF in lower limb.
- Coagulation disorder (outside of VKA use).
- Active infection.
- Inability to comply with the protocol requirements.
- Life expectancy less than 1 year due to progressive disease (neoplasia, severe organ failure).
- Follow-up expected to be difficult.
- Patient under guardianship.
Sites / Locations
- Service chirurgie vasculaire, Hôpital Ambroise Paré
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Conventional angioplasty + paclitaxel-coated balloon
Conventional angioplasty + placebo balloon
Arm Description
Treatment of stenosis of AVF by conventional angioplasty + 1 minute additional angioplasty with paclitaxel-coated balloon
Treatment of stenosis of AVF by conventional angioplasty + 1 minute additional angioplasty with placebo balloon.
Outcomes
Primary Outcome Measures
Cumulated incidence of loss of primary patency of AVF
Double-blind comparison of cumulated incidence of primary patency at 6 months after treatment of stenosis of AVF by conventional angioplasty + additional angioplasty.
Cumulated incidence of primary patency loss of AVF at 6 months post procedure.
Secondary Outcome Measures
Cumulated incidence of primary patency loss of the target lesion
Comparison between arms of cumulated incidence of primary patency loss of treated lesion at 3 and 12 months after treatment of stenosis.
By cumulated incidence with no need for target lesion revascularization.
Cumulated incidence of restenosis > 50% at the site of angioplasty
Comparison between the arms of cumulated incidence of restenosis > 50% at the site of angioplasty of treated lesion of AVF, by cumulated incidence with at least one restenosis at angioplasty site at 3, 6 and 12 months.
Cumulated incidence of deteriorating flow rate
Cumulated incidence at 3, 6 and 12 months of deteriorating back to preoperative flow rate of AVF: defined by the difference of flow rate < 20% between preoperative measurement and follow-up measurement.
Incidence of back to preoperative flow rate will be cumulated.
Cumulated incidence of patients with a flow rate < 500 ml / min
Comparison between the arms of cumulated incidence with a flow rate < 500 ml/min after treatments of stenosis.
Cumulative rate of thrombosis
Comparison between the arms at 3, 6 and 12 months cumulative rate of thrombosis, by the proportion of thrombosis of AVF, number of restenosis and number of thrombosis.
Time period before event's appearance
Comparison between the arms time periods before the events' appearance: restenosis at the same site, stenosis at another site, thrombosis of AVF, death.
Cumulated incidence of adverse event (AE)
Comparison between the arms post procedure AE, by cumulated incidences of AE in 12 months post procedure.
Medical costs
Comparison between the arms at 3, 6 and 12 months the costs of treatments of AVF, by direct medical care, initial treatments, monitoring, diagnosis and treatment of complications.
Cumulative incidence of cardiovascular serious adverse event (SAE)
Comparison between the arms at 12 months the cumulative incidence of cardiovascular SAE.
Cumulative incidence of death
Comparison between the arms at 12 months the cumulative incidence of death.
Full Information
NCT ID
NCT02753998
First Posted
April 25, 2016
Last Updated
March 21, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Bard Peripheral Vascular, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02753998
Brief Title
Paclitaxel-coated Balloon Angioplasty Versus Standard Angioplasty for the Treatment of Stenosis of Arteriovenous Fistula
Acronym
ABISS
Official Title
Paclitaxel-coated Balloon Angioplasty Versus Standard Angioplasty for the Treatment of Stenosis of Arteriovenous Fistula
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
February 2022 (Actual)
Study Completion Date
March 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Bard Peripheral Vascular, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this double-blind study is to compare the frequency of primary patency at 6 months in patients with stenosis of arteriovenous fistula (AVF) treated either by conventional angioplasty + angioplasty with balloon impregnated with paclitaxel or by conventional angioplasty + angioplasty with placebo balloon (balloon not impregnated with paclitaxel).
The other objectives of the study are:
To compare the frequency of primary patency at 3 months and 12 months.
To compare the rate of restenosis > 50% at the site of angioplasty at 3, 6 and 12 months.
To compare, at 3, 6 and 12 months, the proportion of patients with arteriovenous fistula deteriorating back to preoperative flow rate (within 20% of preoperative flow rate).
To compare, at 3, 6 and 12 months, the proportion of AVF with a flow rate < 500 ml / min.
To compare, at 3, 6 and 12 months, the cumulative rate of thrombosis.
To compare, at 3, 6 and 12 months, the medical costs related to direct medical care, initial treatments, monitoring, diagnosis and treatments of complications.
Detailed Description
Experimental design: prospective randomized, double blind, multicenter controlled study, with 2 experimental arms.
12 centers will participate in France, targeting to enrol 150 patients in total. Each patient will undergo angiography at the beginning of the intervention in order to confirm the presence of only one stenosis, to assess the degree of stenosis and to evaluate the vascular diameter.
All patients will first undergo angioplasty using standard balloons. thereafter, depending on randomization arm, an additional angioplasty will be performed during 1 minute with a paclitaxel impregnated balloon (active arm) or with a placebo balloon (placebo arm).
The duration of inclusion is planned for 18 months.
Each patient will have a 12-month follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angioplasty, Stenosis of Arteriovenous Fistula
Keywords
Stenosis of arteriovenous fistula, Angioplasty, Paclitaxel-Coated Balloon Angioplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional angioplasty + paclitaxel-coated balloon
Arm Type
Experimental
Arm Description
Treatment of stenosis of AVF by conventional angioplasty + 1 minute additional angioplasty with paclitaxel-coated balloon
Arm Title
Conventional angioplasty + placebo balloon
Arm Type
Placebo Comparator
Arm Description
Treatment of stenosis of AVF by conventional angioplasty + 1 minute additional angioplasty with placebo balloon.
Intervention Type
Combination Product
Intervention Name(s)
Additional angioplasty with paclitaxel-coated balloon
Other Intervention Name(s)
Lutonix® 035 balloon
Intervention Description
Additional angioplasty with paclitaxel-coated balloon after conventional angioplasty
Intervention Type
Combination Product
Intervention Name(s)
Additional angioplasty with placebo balloon
Other Intervention Name(s)
ClearPAC Omega® balloon
Intervention Description
Additional angioplasty with placebo balloon after conventional angioplasty
Intervention Type
Procedure
Intervention Name(s)
Conventional angioplasty
Primary Outcome Measure Information:
Title
Cumulated incidence of loss of primary patency of AVF
Description
Double-blind comparison of cumulated incidence of primary patency at 6 months after treatment of stenosis of AVF by conventional angioplasty + additional angioplasty.
Cumulated incidence of primary patency loss of AVF at 6 months post procedure.
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Cumulated incidence of primary patency loss of the target lesion
Description
Comparison between arms of cumulated incidence of primary patency loss of treated lesion at 3 and 12 months after treatment of stenosis.
By cumulated incidence with no need for target lesion revascularization.
Time Frame
At 3 months and 12 months
Title
Cumulated incidence of restenosis > 50% at the site of angioplasty
Description
Comparison between the arms of cumulated incidence of restenosis > 50% at the site of angioplasty of treated lesion of AVF, by cumulated incidence with at least one restenosis at angioplasty site at 3, 6 and 12 months.
Time Frame
At 3, 6 and 12 months
Title
Cumulated incidence of deteriorating flow rate
Description
Cumulated incidence at 3, 6 and 12 months of deteriorating back to preoperative flow rate of AVF: defined by the difference of flow rate < 20% between preoperative measurement and follow-up measurement.
Incidence of back to preoperative flow rate will be cumulated.
Time Frame
At 3, 6 and 12 months
Title
Cumulated incidence of patients with a flow rate < 500 ml / min
Description
Comparison between the arms of cumulated incidence with a flow rate < 500 ml/min after treatments of stenosis.
Time Frame
At 3, 6 and 12 months
Title
Cumulative rate of thrombosis
Description
Comparison between the arms at 3, 6 and 12 months cumulative rate of thrombosis, by the proportion of thrombosis of AVF, number of restenosis and number of thrombosis.
Time Frame
At 3, 6 and 12 months
Title
Time period before event's appearance
Description
Comparison between the arms time periods before the events' appearance: restenosis at the same site, stenosis at another site, thrombosis of AVF, death.
Time Frame
At 12 months
Title
Cumulated incidence of adverse event (AE)
Description
Comparison between the arms post procedure AE, by cumulated incidences of AE in 12 months post procedure.
Time Frame
At 12 months
Title
Medical costs
Description
Comparison between the arms at 3, 6 and 12 months the costs of treatments of AVF, by direct medical care, initial treatments, monitoring, diagnosis and treatment of complications.
Time Frame
At 3, 6 and 12 months
Title
Cumulative incidence of cardiovascular serious adverse event (SAE)
Description
Comparison between the arms at 12 months the cumulative incidence of cardiovascular SAE.
Time Frame
At 12 months
Title
Cumulative incidence of death
Description
Comparison between the arms at 12 months the cumulative incidence of death.
Time Frame
At 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years, man or woman.
Chronic Hemodialysis.
Native autologous arteriovenous fistula (AVF).
AVF used at least once for hemodialysis.
Preoperative flow measurement of AVF performed by Doppler.
Length of the stenosis <120 mm.
Outer diameter of the target vein <12mm.
Hemodynamically significant Stenosis on AV fistula, defined according to international recommendations with the following two criteria:
stenosis> 50% by Doppler or angiography,
presenting at least one of the following :
increased venous pressure during dialysis (venous pressure > 150 mmHg when blood flow measured at 200-225 ml / min, or venous pressure > 230 mmHg when blood flow measured at 400 ml / min);
disappearance of thrill of AV fistula;
increasing hemostasis time at the end of dialysis (> 20 minutes or increase by >=50% from usual hemostasis time);
recirculation rate > 20%;
flow of AVF < 500 ml / min responsible for a reduction of the flow of the dialysis circuit.
Only one stenosis with significant impact hemodynamically.
Signed informed consent.
Patient has a health insurance.
Exclusion Criteria:
Pregnant or breastfeeding women.
Severe allergy to iodinated contrast agents, or to heparin, or to paclitaxel.
Anastomotic stenosis involving the afferent artery.
Multiple hemodynamically significant stenoses.
Hemodynamically significant central venous stenosis.
Stent already in place in treated vascular site.
Diameter of the vein immediately upstream of stenosis greater than the maximum diameter of active balloon.
AVF in lower limb.
Coagulation disorder (outside of VKA use).
Active infection.
Inability to comply with the protocol requirements.
Life expectancy less than 1 year due to progressive disease (neoplasia, severe organ failure).
Follow-up expected to be difficult.
Patient under guardianship.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphaël Coscas, MD, PhD
Organizational Affiliation
Service chirurgie vasculaire, Hôpital Ambroise Paré
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service chirurgie vasculaire, Hôpital Ambroise Paré
City
Boulogne-Billancourt
State/Province
Hauts-de-Seine
ZIP/Postal Code
92100
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Paclitaxel-coated Balloon Angioplasty Versus Standard Angioplasty for the Treatment of Stenosis of Arteriovenous Fistula
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