AngioplastyPhase 3ABISSNCT02753998
Paclitaxel-coated Balloon Angioplasty Versus Standard Angioplasty for the Treatment of Stenosis of Arteriovenous Fistula
A Phase 3 study testing Additional angioplasty with paclitaxel-coated balloon and Conventional angioplasty in people with Angioplasty and Stenosis of Arteriovenous Fistula, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioplasty, Stenosis of Arteriovenous Fistula
- What is being tested?
- Additional angioplasty with paclitaxel-coated balloon and Conventional angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2016to Mar 2022
- Phase
- Phase 3
- 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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Service chirurgie vasculaire, Hôpital Ambroise Paré
Boulogne-Billancourt, Hauts-de-Seine, 92100
About this study
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.
Read the 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.
- Conditions
- Angioplasty, Stenosis of Arteriovenous Fistula
- Being tested
- Additional angioplasty with paclitaxel-coated balloon, Additional angioplasty with placebo balloon, Conventional angioplasty
- Keywords
- Stenosis of arteriovenous fistula, Angioplasty, Paclitaxel-Coated Balloon Angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional angioplasty with paclitaxel-coated balloonCombination product
Also called Lutonix® 035 balloon
Additional angioplasty with paclitaxel-coated balloon after conventional angioplasty
Additional angioplasty with placebo balloonCombination product
Also called ClearPAC Omega® balloon
Additional angioplasty with placebo balloon after conventional angioplasty
Conventional angioplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Conventional angioplasty + paclitaxel-coated balloon | Experimental | Treatment of stenosis of AVF by conventional angioplasty + 1 minute additional angioplasty with paclitaxel-coated balloon Receives: Combination Product: Additional angioplasty with paclitaxel-coated balloon; Procedure: Conventional angioplasty |
| Conventional angioplasty + placebo balloon | Placebo comparator | Treatment of stenosis of AVF by conventional angioplasty + 1 minute additional angioplasty with placebo balloon. Receives: Combination Product: Additional angioplasty with placebo balloon; Procedure: Conventional angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months
Secondary outcomes (10)
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.
Measured: At 3 months and 12 months
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.
Measured: 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.
Measured: At 3, 6 and 12 months
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.
Measured: At 3, 6 and 12 months
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.
Measured: At 3, 6 and 12 months
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.
Measured: At 12 months
Cumulated incidence of adverse event (AE)
Comparison between the arms post procedure AE, by cumulated incidences of AE in 12 months post procedure.
Measured: At 12 months
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.
Measured: At 3, 6 and 12 months
Cumulative incidence of cardiovascular serious adverse event (SAE)
Comparison between the arms at 12 months the cumulative incidence of cardiovascular SAE.
Measured: At 12 months
Cumulative incidence of death
Comparison between the arms at 12 months the cumulative incidence of death.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startDec 2016
- Primary completionFeb 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AngioplastyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Bard Peripheral Vascular, Inc.
- Responsible party
- Sponsor
- Investigators
- Raphaël Coscas, MD, PhD, Principal investigator, Service chirurgie vasculaire, Hôpital Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753998
- Sponsor's protocol ID
- P150908
- Acronym
- ABISS
- Status last verified
- Mar 2022
- First submitted
- 25 Apr 2016
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Coscas R, Grimaldi L, Mercier L, Picard E, Ferrario A, Touma J, Mallios A, Sznajder M, Nkam L, Massy ZA; ABISS Investigators. A Randomised Trial of Paclitaxel Coated Balloons in Arteriovenous Fistula Stenosis with Blinded Re-intervention Criteria. Eur J Vasc Endovasc Surg. 2026 Jun 30:S1078-5884(26)00629-5. doi: 10.1016/j.ejvs.2026.06.048. Online ahead of print.
PubMed 42379345
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel-coated Balloon Angioplasty Versus Standard Angioplasty for the Treatment of Stenosis of Arteriovenous Fistula
- ClinicalTrials.gov ID
- NCT02753998
- Acronym / sponsor ID
- ABISS / P150908
- Conditions
- Angioplasty, Stenosis of Arteriovenous Fistula
- Keywords
- Stenosis of arteriovenous fistula, Angioplasty, Paclitaxel-Coated Balloon Angioplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Bard Peripheral Vascular, Inc.
- Study start
- Dec 2016 (actual)
- Primary completion
- Feb 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 28 Apr 2016 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional angioplasty + paclitaxel-coated balloon | Experimental | Combination Product: Additional angioplasty with paclitaxel-coated balloon, Procedure: Conventional angioplastyTreatment of stenosis of AVF by conventional angioplasty + 1 minute additional angioplasty with paclitaxel-coated balloon |
| Conventional angioplasty + placebo balloon | Placebo comparator | Combination Product: Additional angioplasty with placebo balloon, Procedure: Conventional angioplastyTreatment of stenosis of AVF by conventional angioplasty + 1 minute additional angioplasty with placebo balloon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| Additional angioplasty with paclitaxel-coated balloonAlso: Lutonix® 035 balloonAdditional angioplasty with paclitaxel-coated balloon after conventional angioplasty | Combination product | Conventional angioplasty + paclitaxel-coated balloon |
| Additional angioplasty with placebo balloonAlso: ClearPAC Omega® balloonAdditional angioplasty with placebo balloon after conventional angioplasty | Combination product | Conventional angioplasty + placebo balloon |
| Conventional angioplasty | Procedure or surgery | Conventional angioplasty + paclitaxel-coated balloon, Conventional angioplasty + placebo balloon |
Primary outcome
Cumulated incidence of loss of primary patency of AVF
Time frame: At 6 months
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.
10 secondary outcomes
Cumulated incidence of primary patency loss of the target lesion
Time frame: At 3 months and 12 months
Cumulated incidence of restenosis > 50% at the site of angioplasty
Time frame: At 3, 6 and 12 months
Cumulated incidence of deteriorating flow rate
Time frame: At 3, 6 and 12 months
Cumulated incidence of patients with a flow rate < 500 ml / min
Time frame: At 3, 6 and 12 months
Cumulative rate of thrombosis
Time frame: At 3, 6 and 12 months
Time period before event's appearance
Time frame: At 12 months
Cumulated incidence of adverse event (AE)
Time frame: At 12 months
Medical costs
Time frame: At 3, 6 and 12 months
Cumulative incidence of cardiovascular serious adverse event (SAE)
Time frame: At 12 months
Cumulative incidence of death
Time frame: At 12 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 22 Mar 2022.
- Derived from this study: PubMed 42379345Coscas R, Grimaldi L, Mercier L, Picard E, Ferrario A, Touma J, Mallios A, Sznajder M, Nkam L, Massy ZA; ABISS Investigators. A Randomised Trial of Paclitaxel Coated Balloons in Arteriovenous Fistula Stenosis with Blinded Re-intervention Criteria. Eur J Vasc Endovasc Surg. 2026 Jun 30:S1078-5884(26)00629-5. doi: 10.1016/j.ejvs.2026.06.048. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Raphaël Coscas, MD, PhD principal investigator
Service chirurgie vasculaire, Hôpital Ambroise Paré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Additional angioplasty with paclitaxel-coated balloon and Conventional angioplasty in people with Angioplasty and Stenosis of Arteriovenous Fistula, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 18 inclusion and 14 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 22 Mar 2022. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cumulated incidence of loss of primary patency of AVF (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753998, which also lists 1 linked publication.
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 22 Mar 2022.