Immature Arteriovenous FistulaNCT03245944
Optimal Timing of Percutaneous Intervention in Non-maturing Dialysis Fistulas
A study testing early Angioplasty and late Angioplasty in people with Immature Arteriovenous Fistula, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but many of them fail to mature. The optimal timing of intervention to salvage immature AVFs is unknown.The study proposes a randomized clinical trial comparing the clinical and economic impact of early vs late angioplasty in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immature Arteriovenous Fistula
- What is being tested?
- early Angioplasty and late Angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 1 Mar 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
- Patients with End stage renal disease (ESRD).
- Patients on hemodialysis.
- Patients using central venous catheter (CVC).
- Patients who had a new AVF created after commencing dialysis.
- Patients who had immature fistula ( 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min).
Who cannot join
- Children with Age below 18
Trial locations and contacts
1 site in 1 country.
About this study
Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but many of them fail to mature. The optimal timing of intervention to salvage immature AVFs is unknown.The study proposes a randomized clinical trial comparing the clinical and economic impact of early vs late angioplasty in non-maturing AVFs.
The study proposes a RCT to test the hypothesis that, as compared to early angioplasty of non-maturing AVFs, late angioplasty results in a lower proportion of AVFs being used at 6 months, but a greater long-term AVF patency , lower requirement of subsequent interventions to maintain AVF patency for dialysis, and lower overall cost of access maintenance.
Read the detailed description
The optimal timing of intervention in non-maturing AVFs remains controversial, and can only be definitively addressed by a randomized clinical trial (RCT) comparing early (6 weeks) vs late (3 months) angioplasty of non-maturing AVFs. The investigators will perform a single-center, prospective RCT. The investigators will recruit 112 patients who initiated hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min). These patients will be randomized to one of two groups: an early intervention group that will undergo a routine PTA at 6 weeks after AVF creation, or a late intervention group in which early PTA will be avoided and subsequently be performed only if the 3-month ultrasound indicates persistent AVF immaturity. These patients will be followed for 2 years.
- Conditions
- Immature Arteriovenous Fistula
- Being tested
- early Angioplasty, late Angioplasty
- Keywords
- immature AVF, percutaneous intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early AngioplastyProcedure or surgery
Also called Early PTA
Angioplasty is a minimally invasive, endovascular procedure to widen narrowed or obstructed arteries or veins. A deflated balloon attached to a catheter (a balloon catheter) is passed over a guide-wire into the narrowed vessel and then inflated to a fixed size. The balloon forces expansion of the blood vessel and the surrounding muscular wall, allowing an improved blood flow. This is part of standard of care for immature arteriovenous fistulas. Early means pt will get the procedure at 6 weeks from time of initiation of AVFs
late AngioplastyProcedure or surgery
Also called Late PTA
Angioplasty is a minimally invasive, endovascular procedure to widen narrowed or obstructed arteries or veins. A deflated balloon attached to a catheter (a balloon catheter) is passed over a guide-wire into the narrowed vessel and then inflated to a fixed size. The balloon forces expansion of the blood vessel and the surrounding muscular wall, allowing an improved blood flow. This is part of standard of care for immature arteriovenous fistulas. Late means the angioplasty is done at 3 months from time of AVF creation if still immature at that time.
| Study group | Role | What they receive |
|---|---|---|
| early angioplasty | Active comparator | Patients who initiated hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min). These patients who an early angioplasty intervention group that will undergo a routine Angioplasty at 6 weeks after AVF creation Receives: Procedure: early Angioplasty |
| late Angioplasty | Experimental | Patients who initiated hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min). These patients who a late angioplasty intervention group in which early Angioplasty will be avoided and subsequently be performed only if the 3-month ultrasound indicates persistent AVF immaturity Receives: Procedure: late Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula Maturity
Ultrasound of the fistula:
Mature fistula Criteria:
- Blood flow of at least 500 ml/min and
- Minimum diameter of 4 mm
Measured: baseline- 6 months
Secondary outcomes (2)
Fistula survival
Ultrasound of the fistula:
- Blood flow of at least 500 ml/min and
- Minimum diameter of 4 mm
Measured: baseline-2 years
Fistula adequacy
Fistula is used for hemodilaysis and provide adequate clearance which is measured by:
Kt/V: 1.4 where K: clearance [m3/s], t: time [m3/s], V:volume of distribution [m3]
Measured: Baseline- 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start1 Mar 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immature Arteriovenous FistulaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alian Al-Balas, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245944
- Sponsor's protocol ID
- F0001
- Status last verified
- Apr 2020
- First submitted
- 31 Jul 2017
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al-Balas A, Lee T, Young CJ, Barker-Finkel J, Allon M. Predictors of Initiation for Predialysis Arteriovenous Fistula. Clin J Am Soc Nephrol. 2016 Oct 7;11(10):1802-1808. doi: 10.2215/CJN.00700116. Epub 2016 Sep 14.
PubMed 27630181Al-Balas A, Lee T, Young CJ, Kepes JA, Barker-Finkel J, Allon M. The Clinical and Economic Effect of Vascular Access Selection in Patients Initiating Hemodialysis with a Catheter. J Am Soc Nephrol. 2017 Dec;28(12):3679-3687. doi: 10.1681/ASN.2016060707. Epub 2017 Jul 14.
PubMed 28710090
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing of Percutaneous Intervention in Non-maturing Dialysis Fistulas
- ClinicalTrials.gov ID
- NCT03245944
- Acronym / sponsor ID
- F0001
- Conditions
- Immature Arteriovenous Fistula
- Keywords
- immature AVF, percutaneous intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 10 Aug 2017 (actual)
- 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.
Arteriovenous fistulas (AVFs) are the preferred type of vascular access for dialysis, but many of them fail to mature. The optimal timing of intervention to salvage immature AVFs is unknown.The study proposes a randomized clinical trial comparing the clinical and economic impact of early vs late angioplasty in non-maturing AVFs.
The study proposes a RCT to test the hypothesis that, as compared to early angioplasty of non-maturing AVFs, late angioplasty results in a lower proportion of AVFs being used at 6 months, but a greater long-term AVF patency , lower requirement of subsequent interventions to maintain AVF patency for dialysis, and lower overall cost of access maintenance.
Detailed description
The optimal timing of intervention in non-maturing AVFs remains controversial, and can only be definitively addressed by a randomized clinical trial (RCT) comparing early (6 weeks) vs late (3 months) angioplasty of non-maturing AVFs. The investigators will perform a single-center, prospective RCT. The investigators will recruit 112 patients who initiated hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min). These patients will be randomized to one of two groups: an early intervention group that will undergo a routine PTA at 6 weeks after AVF creation, or a late intervention group in which early PTA will be avoided and subsequently be performed only if the 3-month ultrasound indicates persistent AVF immaturity. These patients will be followed for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early angioplasty | Active comparator | Procedure: early AngioplastyPatients who initiated hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min). These patients who an early angioplasty intervention group that will undergo a routine Angioplasty at 6 weeks after AVF creation |
| late Angioplasty | Experimental | Procedure: late AngioplastyPatients who initiated hemodialysis with a CVC, then had a new AVF created after commencing dialysis, and then had a 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min). These patients who a late angioplasty intervention group in which early Angioplasty will be avoided and subsequently be performed only if the 3-month ultrasound indicates persistent AVF immaturity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with End stage renal disease (ESRD).
- Patients on hemodialysis.
- Patients using central venous catheter (CVC).
- Patients who had a new AVF created after commencing dialysis.
- Patients who had immature fistula ( 6-week postoperative ultrasound that revealed an immature AVF (diameter < 4 mm diameter or blood flow < 500 ml/min).
Key exclusion criteria (1 listed)
- Children with Age below 18
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 |
|---|---|---|
| early AngioplastyAlso: Early PTAAngioplasty is a minimally invasive, endovascular procedure to widen narrowed or obstructed arteries or veins. A deflated balloon attached to a catheter (a balloon catheter) is passed over a guide-wire into the narrowed vessel and then inflated to a fixed size. The balloon forces expansion of the blood vessel and the surrounding muscular wall, allowing an improved blood flow. This is part of standard of care for immature arteriovenous fistulas. Early means pt will get the procedure at 6 weeks from time of initiation of AVFs | Procedure or surgery | early angioplasty |
| late AngioplastyAlso: Late PTAAngioplasty is a minimally invasive, endovascular procedure to widen narrowed or obstructed arteries or veins. A deflated balloon attached to a catheter (a balloon catheter) is passed over a guide-wire into the narrowed vessel and then inflated to a fixed size. The balloon forces expansion of the blood vessel and the surrounding muscular wall, allowing an improved blood flow. This is part of standard of care for immature arteriovenous fistulas. Late means the angioplasty is done at 3 months from time of AVF creation if still immature at that time. | Procedure or surgery | late Angioplasty |
Primary outcome
Fistula Maturity
Time frame: baseline- 6 months
Ultrasound of the fistula: Mature fistula Criteria: 1. Blood flow of at least 500 ml/min and 2. Minimum diameter of 4 mm
2 secondary outcomes
Fistula survival
Time frame: baseline-2 years
Fistula adequacy
Time frame: Baseline- 2 years
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 27 Apr 2020.
- Background: PubMed 27630181Al-Balas A, Lee T, Young CJ, Barker-Finkel J, Allon M. Predictors of Initiation for Predialysis Arteriovenous Fistula. Clin J Am Soc Nephrol. 2016 Oct 7;11(10):1802-1808. doi: 10.2215/CJN.00700116. Epub 2016 Sep 14.
- Background: PubMed 28710090Al-Balas A, Lee T, Young CJ, Kepes JA, Barker-Finkel J, Allon M. The Clinical and Economic Effect of Vascular Access Selection in Patients Initiating Hemodialysis with a Catheter. J Am Soc Nephrol. 2017 Dec;28(12):3679-3687. doi: 10.1681/ASN.2016060707. Epub 2017 Jul 14.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early Angioplasty and late Angioplasty in people with Immature Arteriovenous Fistula, run by University of Alabama at Birmingham at 1 site in United States.
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 5 inclusion and 1 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 27 Apr 2020. 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 United States. 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?
Fistula Maturity (time frame: baseline- 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 NCT03245944, which also lists 2 linked publications.
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 27 Apr 2020.