Native Arteriovenous FistulaDeVANCT02902094
Drug Eluting Balloon Venoplasty in AV Fistula Stenosis
A study testing Drug eluting balloons and Non drug eluting balloons in people with Native Arteriovenous Fistula and Stenosis, run by University Hospital Birmingham at 1 site in United Kingdom.
Trial summary
DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty balloon in patients with symptomatic native AV fistula stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Native Arteriovenous Fistula, Stenosis
- What is being tested?
- Drug eluting balloons and Non drug eluting balloons
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Jan 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
- Arteriovenous (AV) fistulas with stenosis requiring percutaneous angioplasty identified on routine diagnostic imaging or causing clinical concern on dialysis.
- Fistula has been in use for at least 1 month and is > 6 weeks old
- Brachiocephalic AV fistula
- Brachiobasilic AV fistula
- Radiocephalic AV fistula (both proximal and distal)
- Participant >/=18 yrs old
- Index lesion is less then the length of the DEB, and the reference vessel diameter is appropriate for treatment with the size range of DEB (4mm - 8mm diameter)
- Participant is able to give valid informed consent
Who cannot join
- Allergy to iodinated Intravenous contrast
- Allergy to Paclitaxel
- Prosthetic grafts
- Long or tandem lesions that cannot be treated with a single DEB
- Thrombosed Arterio-Venous fistulas
- Women who are breastfeeding, pregnant or intending to become pregnant
- Participants of child-bearing age who are unwilling to use a reliable form of contraception for the duration of the study.
Trial locations and contacts
1 site in 1 country.
N E Anderson contact
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2TH
R G Jones, Dr
About this study
Official title: Improving Outcomes in Fistula Intervention: A Prospective, Patient Blinded, Phase 3, Randomised Controlled Trial of Drug Eluting Balloons in the Angioplasty of Native Haemodialysis Access Arteriovenous Fistula Outflow Stenosis (DeVA)
DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty balloon in patients with symptomatic native AV fistula stenosis.
- Conditions
- Native Arteriovenous Fistula, Stenosis
- Being tested
- Drug eluting balloons, Non drug eluting balloons
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug eluting balloonsDevice
Non drug eluting balloonsDevice
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Drug eluting angioplasty balloons Receives: Device: Drug eluting balloons |
| Control | Active comparator | Non-drug eluting balloons Receives: Device: Non drug eluting balloons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency
Primary end point is a composite of one or more of :
- >50% stenosis of index lesion requiring re-intervention
- Re-intervention of index lesion due to clinical indications without 50% re-stenosis
- Fistula failure
Measured: 12 months
Secondary outcomes (4)
Technical success
Defined as <30% residual stenosis using only the study balloon to which the patient was randomised
Measured: Time of baseline index intervention
Assisted technical success of balloon angioplasty
Defined as <30% residual stenosis using adjunctive procedures in addition to study balloon
Measured: At time of baseline index intervention
Successful use of fistula for dialysis
Defined as successful use of the fistula for dialysis using 2 needles on at least one occasion
Measured: In the 12 months following baseline index intervention
Secondary patency of the access circuit
Measured: In the 12 months following baseline index intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Native 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Robert Jones, Dr, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902094
- Sponsor's protocol ID
- RRK5479
- Acronym
- DeVA
- Status last verified
- Sep 2016
- First submitted
- 21 Jun 2016
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes in Fistula Intervention: A Prospective, Patient Blinded, Phase 3, Randomised Controlled Trial of Drug Eluting Balloons in the Angioplasty of Native Haemodialysis Access Arteriovenous Fistula Outflow Stenosis (DeVA)
- ClinicalTrials.gov ID
- NCT02902094
- Acronym / sponsor ID
- DeVA / RRK5479
- Conditions
- Native Arteriovenous Fistula, Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Jan 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 15 Sep 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.
DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty balloon in patients with symptomatic native AV fistula stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Drug eluting balloonsDrug eluting angioplasty balloons |
| Control | Active comparator | Device: Non drug eluting balloonsNon-drug eluting balloons |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Arteriovenous (AV) fistulas with stenosis requiring percutaneous angioplasty identified on routine diagnostic imaging or causing clinical concern on dialysis.
- Fistula has been in use for at least 1 month and is > 6 weeks old
- Brachiocephalic AV fistula
- Brachiobasilic AV fistula
- Radiocephalic AV fistula (both proximal and distal)
Key exclusion criteria (7 listed)
- Allergy to iodinated Intravenous contrast
- Allergy to Paclitaxel
- Prosthetic grafts
- Long or tandem lesions that cannot be treated with a single DEB
- Thrombosed Arterio-Venous fistulas
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 |
|---|---|---|
| Drug eluting balloons | Device | Experimental |
| Non drug eluting balloons | Device | Control |
Primary outcome
Patency
Time frame: 12 months
Primary end point is a composite of one or more of : * >50% stenosis of index lesion requiring re-intervention * Re-intervention of index lesion due to clinical indications without 50% re-stenosis * Fistula failure
4 secondary outcomes
Technical success
Time frame: Time of baseline index intervention
Assisted technical success of balloon angioplasty
Time frame: At time of baseline index intervention
Successful use of fistula for dialysis
Time frame: In the 12 months following baseline index intervention
Secondary patency of the access circuit
Time frame: In the 12 months following baseline index intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Native Arteriovenous Fistula
Recruiting
ACOART AVF RENEW: A Post Market Clinical Study
Stenosis of Native Hemodialysis Arteriovenous Fistulas
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.
N E Anderson contact
Robert Jones, Dr principal investigator
University Hospital Birmingham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug eluting balloons and Non drug eluting balloons in people with Native Arteriovenous Fistula and Stenosis, run by University Hospital Birmingham at 1 site in United Kingdom.
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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Sep 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact N E Anderson (+441216272000), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 15 Sep 2016.