Dysfunctional Dialysis Arteriovenous FistulaNCT03189667
Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula
A study testing Vessel preparation with angioplasty, Plain balloon angioplasty and Drug coated balloon angioplasty in people with Dysfunctional Dialysis Arteriovenous Fistula, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial summary
Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis arteriovenous fistulas (AVFs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysfunctional Dialysis Arteriovenous Fistula
- What is being tested?
- Vessel preparation with angioplasty, Plain balloon angioplasty and Drug coated balloon angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Oct 2017to 5 Feb 2019
- 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
- >18 year old
- Dysfunctional dialysis fistula
- Radiocephalic
- Brachiocephalic
- Brachiobasilic
- Clinical criteria for diagnosis of dysfunctional fistula:
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- Swelling of the fistula limb
- Prolonged bleeding after withdrawing access needles
- Abnormal pulsations or weak thrill.
- Functional criteria for the diagnosis of dysfunctional criteria:
- Arteriovenous fistula is unable to deliver dialysis blood flow (Qb) of equal to or more than 300 ml/min and/or access recirculation of more than 10% on at least two occasions,
- A rising trend of venous pressure or excessive negative arterial pressure, and/or unable to deliver a Kt/v of 1.2 or more.
- Non-thrombosed
Who cannot join
- Dysfunctional arteriovenous (AV) grafts
- Thrombosed fistulas
- Intra-stent stenosis
- Stenoses not responding to balloon angioplasty and requiring stenting.
- Stenosis less than 50%
- Surgical intervention that excludes the treatment segment from the access circuit
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- Systemic or local (to the fistula) infection treated for less than 10 days prior to the study procedure
- Location of isolated stenosis central to the thoracic inlet.
- Women who are breastfeeding, pregnant or are intending to become pregnant
- Known hypersensitivity or contraindication to contrast medium which cannot be adequately premeditated.
- Sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel
Trial locations and contacts
1 site in 1 country.
About this study
Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis arteriovenous fistulas (AVFs).
Read the detailed description
Objectives of the Study:
Hypothesis: Drug-coated balloons improve functional and patency outcomes of failing/dysfunctional hemodialysis fistulas compared to plain uncoated balloons
Aim of the Study:
Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis AVFs.
Specific Objectives:
Primary functional endpoint: Access circuit patency based on functional criteria at 12 month.
Primary safety endpoint: Peri procedural complication rate
Secondary endpoints:
- Technical success (<30% residual stenosis without postdilation)
- Access circuit dysfunction free survival (Time to event) based on functional criteria
- Target lesion restenosis free survival (Time to event) (in case of new lesion causes circuit dysfunction)
- Being tested
- Vessel preparation with angioplasty, Plain balloon angioplasty, Drug coated balloon angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vessel preparation with angioplastyDevice
Vessel preparation with Pre dilatation:
- All lesions to be predilated with high pressure balloons until waist is obliterated.
- At least two minutes dilatation.
- Balloon sizing: not to exceed the average diameter of adjacent normal appearing non-aneurysmal segments by more than 25%.
- Multiple lesions:
- To be treated with single balloon if possible.
- To be treated with multiple inflation if cannot be covered with single balloon.
Plain balloon angioplastyDevice
Plain balloon angioplasty
- Vessel treatment with additional Plain balloon angioplasty:
- Inflation to nominal pressure for at least 1 minute.
- Balloon size: similar to predilation balloon.
Drug coated balloon angioplastyDevice
Lutonix® Drug Coated Balloon: The balloon is coated with a specialized formulation that includes the drug, paclitaxel. The paclitaxel coating is evenly distributed across the working length of the balloon at a surface concentration of 2 μg/mm2. The key functional characteristic of the formulation is to allow for release of paclitaxel to the tissue of the vascular wall during inflation.
- Inflation to nominal pressure for at least 1 minute.
- Balloon size: similar to the predilation balloon.
- New drug coated balloon will be required for each lesion.
| Study group | Role | What they receive |
|---|---|---|
| Drug coated balloon angioplasty | Experimental | * Vessel preparation with Pre dilatation
* Vessel treatment with Drug-coated balloon Receives: Device: Vessel preparation with angioplasty; Device: Drug coated balloon angioplasty |
| Plain balloon angioplasty | Active comparator | * Vessel preparation with Pre dilatation
* Vessel treatment with additional Plain balloon angioplasty: Receives: Device: Vessel preparation with angioplasty; Device: Plain balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
AVF circuit patency
Dialysis adequacy to be assessed based on functional criteria
Measured: 12 month
Secondary outcomes (4)
Technical success
<30% residual stenosis without postdilation
Measured: intra procedural
Access circuit dysfunction free survival
Time to event based on functional criteria
Measured: 12 month
Target lesion restenosis free survival
Time to event in case of new lesion causes circuit dysfunction
Measured: 12 month
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by the Society of Interventional Radiology Clinical Practice Guidelines
Measured: 12 month following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start15 Oct 2017
- Primary completion5 Feb 2019
- Study completion5 Feb 2019
Why it stopped: slow recruitment and recent concerns of safety of Paclitaxel coated balloons and associated increased risk death
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysfunctional Dialysis Arteriovenous FistulaStudies of the same condition, open and under way.
- 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
- Model description
- Open label randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Arabi, MD, Principal investigator, King Abdulaziz Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189667
- Sponsor's protocol ID
- RC16/035/R
- Status last verified
- Apr 2019
- First submitted
- 1 Jun 2017
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula
- ClinicalTrials.gov ID
- NCT03189667
- Acronym / sponsor ID
- RC16/035/R
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment and recent concerns of safety of Paclitaxel coated balloons and associated increased risk death
- Enrolment
- 23 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 5 Feb 2019 (actual)
- First posted
- 16 Jun 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.
Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis arteriovenous fistulas (AVFs).
Detailed description
Objectives of the Study:
Hypothesis: Drug-coated balloons improve functional and patency outcomes of failing/dysfunctional hemodialysis fistulas compared to plain uncoated balloons
Aim of the Study:
Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis AVFs.
Specific Objectives:
Primary functional endpoint: Access circuit patency based on functional criteria at 12 month.
Primary safety endpoint: Peri procedural complication rate
Secondary endpoints:
- Technical success (<30% residual stenosis without postdilation)
- Access circuit dysfunction free survival (Time to event) based on functional criteria
- Target lesion restenosis free survival (Time to event) (in case of new lesion causes circuit dysfunction)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Drug coated balloon angioplasty | Experimental | Device: Vessel preparation with angioplasty, Device: Drug coated balloon angioplasty* Vessel preparation with Pre dilatation * Vessel treatment with Drug-coated balloon |
| Plain balloon angioplasty | Active comparator | Device: Vessel preparation with angioplasty, Device: Plain balloon angioplasty* Vessel preparation with Pre dilatation * Vessel treatment with additional Plain balloon angioplasty: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Radiocephalic
- Brachiocephalic
- Brachiobasilic
- Swelling of the fistula limb
- Prolonged bleeding after withdrawing access needles
Key exclusion criteria (11 listed)
- Dysfunctional arteriovenous (AV) grafts
- Thrombosed fistulas
- Intra-stent stenosis
- Stenoses not responding to balloon angioplasty and requiring stenting.
- Stenosis less than 50%
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 |
|---|---|---|
| Vessel preparation with angioplastyVessel preparation with Pre dilatation: * All lesions to be predilated with high pressure balloons until waist is obliterated. * At least two minutes dilatation. * Balloon sizing: not to exceed the average diameter of adjacent normal appearing non-aneurysmal segments by more than 25%. * Multiple lesions: * To be treated with single balloon if possible. * To be treated with multiple inflation if cannot be covered with single balloon. | Device | Drug coated balloon angioplasty, Plain balloon angioplasty |
| Plain balloon angioplastyPlain balloon angioplasty * Vessel treatment with additional Plain balloon angioplasty: * Inflation to nominal pressure for at least 1 minute. * Balloon size: similar to predilation balloon. | Device | Plain balloon angioplasty |
| Drug coated balloon angioplastyLutonix® Drug Coated Balloon: The balloon is coated with a specialized formulation that includes the drug, paclitaxel. The paclitaxel coating is evenly distributed across the working length of the balloon at a surface concentration of 2 μg/mm2. The key functional characteristic of the formulation is to allow for release of paclitaxel to the tissue of the vascular wall during inflation. * Inflation to nominal pressure for at least 1 minute. * Balloon size: similar to the predilation balloon. * New drug coated balloon will be required for each lesion. | Device | Drug coated balloon angioplasty |
Primary outcome
AVF circuit patency
Time frame: 12 month
Dialysis adequacy to be assessed based on functional criteria
4 secondary outcomes
Technical success
Time frame: intra procedural
Access circuit dysfunction free survival
Time frame: 12 month
Target lesion restenosis free survival
Time frame: 12 month
Number of participants with treatment-related adverse events
Time frame: 12 month following the procedure
Results and safety
The study was stopped early (reason given: slow recruitment and recent concerns of safety of Paclitaxel coated balloons and associated increased risk death). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: No
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.
Mohammad Arabi, MD principal investigator
King Abdulaziz Medical City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vessel preparation with angioplasty, Plain balloon angioplasty and Drug coated balloon angioplasty in people with Dysfunctional Dialysis Arteriovenous Fistula, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
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 13 inclusion and 11 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 1 May 2019. 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 Saudi Arabia. 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: slow recruitment and recent concerns of safety of Paclitaxel coated balloons and associated increased risk death). 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?
AVF circuit patency (time frame: 12 month). 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 1 May 2019.