Arteriovenous FistulaPRESTNCT01321866
Cutting Balloon Versus Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients
A study testing Cutting balloon angioplasty and Angioplasty in people with Arteriovenous Fistula and Fistula, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to evaluate and compare the primary patency rate at 12 months in a group of hemodialysis patients operated on by cutting balloon and in a group of hemodialysis patients operated by conventional balloon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula, Fistula
- What is being tested?
- Cutting balloon angioplasty and Angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Dec 2015
- 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
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 12 months of follow-up
- The patient is on hemodialysis because of chronic renal insufficiency
- The patient's vascular access is an arterio-venous fistula
- The patient has a venous stenosis in the fistula (first event in the studied zone)
- The patient is scheduled for angioplasty
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient cannot fluently read French
Show all 16Show fewer
- The patient cannot understand French
- The patient is pregnant
- The patient is breastfeeding
- Short term dialysis
- The vascular access is a "graft"
- The stenosis in question is a recurrence, and not a first event in the studied zone
- The life expectancy of the patient is < 12 months
- Medical emergency situation
- Peritoneal dialysis
- At-home dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Comparing a Cutting Balloon to a Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients
The main objective of this study is to evaluate and compare the primary patency rate at 12 months in a group of hemodialysis patients operated on by cutting balloon and in a group of hemodialysis patients operated by conventional balloon.
- Conditions
- Arteriovenous Fistula, Fistula
- Being tested
- Cutting balloon angioplasty, Angioplasty
- Keywords
- Angioplasty, cutting balloon
- Medical subject headings
- Arteriovenous Fistula, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutting balloon angioplastyProcedure or surgery
Angioplasty of fistula stenosis using a cutting balloon
AngioplastyProcedure or surgery
Angioplasty of fistula stenosis using a non-cutting balloon
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patients in this arm will have angioplasty of a fistula stenosis using a cutting balloon Receives: Procedure: Cutting balloon angioplasty |
| Standard arm | Active comparator | Patients in this arm will have angioplasty of a fistula stenosis using a non-cutting balloon. Receives: Procedure: Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
Primary patency following a first angioplasty of a first stenose in the affected zone.
Measured: 12 months
Secondary outcomes (23)
Number of early re-stenoses
stenosis defined as lumen diameter < 2mm
Measured: 3 months
Number of re-stenoses
Stenosis defined as lumen diameter < 2mm
Measured: 12 months
Total days in hospital
The total number of days hospitalized for stenosis, thrombosis, or recovering vascular access. This does not include regular hemodialysis activities.
Measured: 12 months
Number of stents used
The total number of stents placed between the study angioplasty and the end-of-study visit.
Measured: 12 months
Total number of venous thromboses
Total number of venous thromboses between study angioplasty and end-of-study visit
Measured: 12 months
Direct medical costs (€)
Measured: 12 months
Indirect costs (€)
Measured: 12 months
Questionnaire KDQOL
Measured: 12 months
Questionnaire SF36
Measured: 12 months
Questionnaire KDQOL
Measured: 3 months
Questionnaire KDQOL
Measured: 6 months
Questionnaire SF36
Measured: 3 months
Questionnaire SF36
Measured: 6 months
Fistula quality (cm*ml/min)
cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min)
Measured: Baseline
Fistula quality (cm*ml/min)
cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min)
Measured: 6 months
Fistula quality (cm*ml/min)
cumulative length of "usable" fistula (cm) * venous flow during the last hemodialysis (ml/min)
Measured: 12 months
% Stenosis
100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100)
Measured: Baseline
% Stenosis
100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100)
Measured: 6 months
% Stenosis
100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100)
Measured: 12 months
Presence/absence of complications associated with the angioplasty
Measured: Day of intervention
% Stenosis
100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))*100)
Measured: 3 months
Presence/absence of complications since the last visit
Measured: 6 months
Presence/absence of complications since the last visit
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startMay 2012
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Inclusion curve too slow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Picard, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321866
- Sponsor's protocol ID
- AOI/2010/EP-01
- Other IDs
- 2011-A00332-39
- Acronym
- PREST
- Status last verified
- Jun 2016
- First submitted
- 23 Mar 2011
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing a Cutting Balloon to a Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients
- ClinicalTrials.gov ID
- NCT01321866
- Acronym / sponsor ID
- PREST / AOI/2010/EP-01
- Conditions
- Arteriovenous Fistula, Fistula
- Keywords
- Angioplasty, cutting balloon
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion curve too slow.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Mar 2011 (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 main objective of this study is to evaluate and compare the primary patency rate at 12 months in a group of hemodialysis patients operated on by cutting balloon and in a group of hemodialysis patients operated by conventional balloon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Procedure: Cutting balloon angioplastyPatients in this arm will have angioplasty of a fistula stenosis using a cutting balloon |
| Standard arm | Active comparator | Procedure: AngioplastyPatients in this arm will have angioplasty of a fistula stenosis using a non-cutting balloon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 12 months of follow-up
- The patient is on hemodialysis because of chronic renal insufficiency
- The patient's vascular access is an arterio-venous fistula
Key exclusion criteria (16 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| Cutting balloon angioplastyAngioplasty of fistula stenosis using a cutting balloon | Procedure or surgery | Experimental arm |
| AngioplastyAngioplasty of fistula stenosis using a non-cutting balloon | Procedure or surgery | Standard arm |
Primary outcome
Primary patency
Time frame: 12 months
Primary patency following a first angioplasty of a first stenose in the affected zone.
23 secondary outcomes
Number of early re-stenoses
Time frame: 3 months
Number of re-stenoses
Time frame: 12 months
Total days in hospital
Time frame: 12 months
Number of stents used
Time frame: 12 months
Total number of venous thromboses
Time frame: 12 months
Direct medical costs (€)
Time frame: 12 months
Indirect costs (€)
Time frame: 12 months
Questionnaire KDQOL
Time frame: 12 months
Questionnaire SF36
Time frame: 12 months
Questionnaire KDQOL
Time frame: 3 months
Questionnaire KDQOL
Time frame: 6 months
Questionnaire SF36
Time frame: 3 months
Questionnaire SF36
Time frame: 6 months
Fistula quality (cm*ml/min)
Time frame: Baseline
Fistula quality (cm*ml/min)
Time frame: 6 months
Fistula quality (cm*ml/min)
Time frame: 12 months
% Stenosis
Time frame: Baseline
% Stenosis
Time frame: 6 months
% Stenosis
Time frame: 12 months
Presence/absence of complications associated with the angioplasty
Time frame: Day of intervention
% Stenosis
Time frame: 3 months
Presence/absence of complications since the last visit
Time frame: 6 months
Presence/absence of complications since the last visit
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Inclusion curve too slow.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
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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.
Eric Picard, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cutting balloon angioplasty and Angioplasty in people with Arteriovenous Fistula and Fistula, run by Centre Hospitalier Universitaire de Nīmes 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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 3 Jun 2016. 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. 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 was stopped early (reason given: Inclusion curve too slow.). Results are not available in the source record.
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?
Primary patency (time frame: 12 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 3 Jun 2016; AzTrials last refreshed its copy on 7 Nov 2026.