Arteriovenous Fistula StenosisPhase 1CONCERTONCT05961852
COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)
A Phase 1 study testing Angioplasty in people with Arteriovenous Fistula Stenosis, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for the treatment of resistant AVF stenosis. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Arteriovenous Fistula Stenosis
- What is being tested?
- Angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Aug 2018to 30 Jun 2019
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Failing mature upper limb AVF
- Resistant stenosis (>30% residual stenosis) after optimal conventional balloon angioplasty (appropriately sized balloon, inflated up to rated burst pressure, at least twice for at least a minute per inflation)
- Patient is >= 21 years of age
- Ability to provide informed consent
Who cannot join
- Thrombosed AVF
- Target lesion has a sharp angle (> 45 degrees)
- Lesions requiring cutting balloon size > 7 mm
- Coagulopathy or thrombocytopaenia that cannot be adequately managed for the procedure
- Contraindication to dual antiplatelet therapy
- Severe allergy to contrast media that cannot be adequately managed for the procedure
Show all 9Show fewer
- Breast-feeding and/or pregnant females
- Male patients who are planning to father children during the trial period
- Unable to comply with follow up protocol (for instance, limited life expectancy)
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for the treatment of resistant AVF stenosis.
Read the detailed description
This is a single arm pilot study recruiting 19 participants with resistant AVF stenosis (defined as having > 30% residual stenosis after optimal balloon angioplasty) to receive cutting and drug-coated balloon.
The outcome measure is target lesion primary patency at 6 months. Outcome will be clinically driven.
- Conditions
- Arteriovenous Fistula Stenosis
- Being tested
- Angioplasty
- Keywords
- arteriovenous fistula, drug-coated balloon, cutting balloon, stenosis
- Medical subject headings
- Arteriovenous Fistula, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioplastyDevice
Angioplasty with cutting and drug-coated balloon
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Cutting and drug-coated balloon angioplasty Receives: Device: Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion primary patency
Time from index treatment to repeat treatment of target lesion or thrombosis of circuit.
Measured: 6 months after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start15 Aug 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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 Arteriovenous Fistula StenosisStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
- Investigators
- Kun Da Zhuang, MBBS, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961852
- Sponsor's protocol ID
- CONCERTO
- Acronym
- CONCERTO
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wu CC, Lin MC, Pu SY, Tsai KC, Wen SC. Comparison of cutting balloon versus high-pressure balloon angioplasty for resistant venous stenoses of native hemodialysis fistulas. J Vasc Interv Radiol. 2008 Jun;19(6):877-83. doi: 10.1016/j.jvir.2008.02.016. Epub 2008 May 2.
PubMed 18503902
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)
- ClinicalTrials.gov ID
- NCT05961852
- Acronym / sponsor ID
- CONCERTO / CONCERTO
- Conditions
- Arteriovenous Fistula Stenosis
- Keywords
- arteriovenous fistula, drug-coated balloon, cutting balloon, stenosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 27 Jul 2023 (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.
To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for the treatment of resistant AVF stenosis.
Detailed description
This is a single arm pilot study recruiting 19 participants with resistant AVF stenosis (defined as having > 30% residual stenosis after optimal balloon angioplasty) to receive cutting and drug-coated balloon.
The outcome measure is target lesion primary patency at 6 months. Outcome will be clinically driven.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: AngioplastyCutting and drug-coated balloon angioplasty |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Failing mature upper limb AVF
- Resistant stenosis (>30% residual stenosis) after optimal conventional balloon angioplasty (appropriately sized balloon, inflated up to rated burst pressure, at least twice for at least a minute per inflation)
- Patient is >= 21 years of age
- Ability to provide informed consent
Key exclusion criteria (9 listed)
- Thrombosed AVF
- Target lesion has a sharp angle (> 45 degrees)
- Lesions requiring cutting balloon size > 7 mm
- Coagulopathy or thrombocytopaenia that cannot be adequately managed for the procedure
- Contraindication to dual antiplatelet therapy
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 |
|---|---|---|
| AngioplastyAngioplasty with cutting and drug-coated balloon | Device | Treatment arm |
Primary outcome
Target lesion primary patency
Time frame: 6 months after index procedure
Time from index treatment to repeat treatment of target lesion or thrombosis of circuit.
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 Jul 2023.
- Background: PubMed 18503902Wu CC, Lin MC, Pu SY, Tsai KC, Wen SC. Comparison of cutting balloon versus high-pressure balloon angioplasty for resistant venous stenoses of native hemodialysis fistulas. J Vasc Interv Radiol. 2008 Jun;19(6):877-83. doi: 10.1016/j.jvir.2008.02.016. Epub 2008 May 2.
- Individual participant dataSharing planned: Undecided
Related trials for Arteriovenous Fistula Stenosis
Not yet recruiting
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
Active, not recruitingObservational study
Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)
Venous Stenosis, Venous Occlusion
Active, not recruitingObservational study
Florida Cerebrovascular Disease Biorepository and Genomics Center
Cerebrovascular Disease, Ischemic Stroke
RecruitingObservational study
WRAP North America
Venous Stenosis, Venous Occlusion
Active, not recruiting
A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis (RANGER AV Japan Study)
Arteriovenous Fistula Stenosis, Arteriovenous Fistula
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.
Kun Da Zhuang, MBBS principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Angioplasty in people with Arteriovenous Fistula Stenosis, run by Singapore General Hospital at 1 site in Singapore.
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 4 inclusion and 9 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 Jul 2023. 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 Singapore. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Target lesion primary patency (time frame: 6 months after index procedure). 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 NCT05961852, 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 27 Jul 2023.