Dialysis Access MalfunctionPhase 2INSTITUTIONNCT05018962
Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: CuttIng ballooN angioplaSTy Combined wITh Paclitaxel drUg coaTed Balloon Angioplasty, an observatIONal Clinical Study
A Phase 2 study testing Cutting balloon followed by paclitaxel coated balloon in people with Dialysis Access Malfunction, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
To determine if cutting balloon angioplasty combined with DEB angioplasty provides a higher primary patency after treatment of recurrent stenoses compared with cutting balloon angioplasty or angioplasty using DEB alone in the venous outflow AVFs. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dialysis Access Malfunction
- What is being tested?
- Cutting balloon followed by paclitaxel coated balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Sep 2017to 18 Mar 2020
- Phase
- Phase 2
- 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
- Recurrent stenoses (within 1 year after angioplasty) in the venous outflow of AVFs for dialysis access (> 0.5cm from AV anastomosis up to cephalic arch)
- Successful guidewire crossing of target lesion
- ≥ 21 years old
- Informed and valid consent given.
- Patient willing and able to return for follow up .
Who cannot join
- Thrombosed AVFs or occlusions in the access circuit
- Significant cephalic arch (central perpendicular portion of the cephalic vein) or central vein stenoses.
- > 3 stenosed segments (lesions are considered separate if they are separated by at least 2 cm normal vessel.)
- Only potential target lesion located in cephalic arch, central veins or anastomotic lesions.
- Only de novo stenoses identifiable as target lesion.
- Target lesion resistant to cutting balloon angioplasty (>30% residual stenosis with incomplete effacement of the lesion during cutting balloon angioplasty)
Show all 17Show fewer
- Target lesion not treatable with the available sizes of cutting balloon (4-7mm) and drug eluting balloon (up to 8mm) so native reference vessel <3 mm or need for DEB balloon >8mm.
- Lesion in excess of 8 cm
- Unable to take dual antiplatelet therapy for 1 month and/or aspirin for 6 months
- Coagulopathy (PT or PTT >1.5 times the median of normal range) or thrombocytopenia (platelet count <50,000 /μL) that cannot be managed adequately with periprocedural transfusion.
- Patient on Warfarin.
- Known allergy to iodinated contrast that cannot be managed adequately with pre-procedure medication.
- Allergy / contraindication to dual anti-platelet therapy (aspirin and clopidogrel or ticlopidine) or paclitaxel.
- Acute infection over proposed puncture site.
- Women who are breastfeeding, pregnant or planning on becoming pregnant during study.
- Participant with medical conditions, which in the opinion of the investigator may cause non-compliance with protocol.
- Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.
Trial locations and contacts
1 site in 1 country.
About this study
To determine if cutting balloon angioplasty combined with DEB angioplasty provides a higher primary patency after treatment of recurrent stenoses compared with cutting balloon angioplasty or angioplasty using DEB alone in the venous outflow AVFs. For cutting balloon angioplasty in venous stenosis, the primary patency after 12 months is 55-60% (9,16) and in recurrent stenoses up to 48%(10).
We hypothesise that DEB angioplasty after cutting balloon angioplasty leads to improved primary patency at 12 months.
- Conditions
- Dialysis Access Malfunction
- Being tested
- Cutting balloon followed by paclitaxel coated balloon
- Keywords
- Paclitaxel coated balloon, Cutting balloon, Recurrent stenosis
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutting balloon followed by paclitaxel coated balloonDevice
Cutting balloon followed by paclitaxel coated balloon
| Study group | Role | What they receive |
|---|---|---|
| Cutting balloon followed by paclitaxel coated balloon | Experimental | Not described Receives: Device: Cutting balloon followed by paclitaxel coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion primary patency
Target lesion primary patency
Measured: 1 year
Secondary outcomes (2)
Circuit primary patency
Circuit primary patency
Measured: 1 year
Target lesion primary assisted patency
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start8 Sep 2017
- Primary completion15 Apr 2019
- Study completion18 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis Access MalfunctionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018962
- Sponsor's protocol ID
- 2017/2046
- Acronym
- INSTITUTION
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Stenoses in Arteriovenous Fistula (AVF) for Dialysis Access: CuttIng ballooN angioplaSTy Combined wITh Paclitaxel drUg coaTed Balloon Angioplasty, an observatIONal Clinical Study
- ClinicalTrials.gov ID
- NCT05018962
- Acronym / sponsor ID
- INSTITUTION / 2017/2046
- Conditions
- Dialysis Access Malfunction
- Keywords
- Paclitaxel coated balloon, Cutting balloon, Recurrent stenosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 24 Aug 2021 (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 determine if cutting balloon angioplasty combined with DEB angioplasty provides a higher primary patency after treatment of recurrent stenoses compared with cutting balloon angioplasty or angioplasty using DEB alone in the venous outflow AVFs. For cutting balloon angioplasty in venous stenosis, the primary patency after 12 months is 55-60% (9,16) and in recurrent stenoses up to 48%(10).
We hypothesise that DEB angioplasty after cutting balloon angioplasty leads to improved primary patency at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cutting balloon followed by paclitaxel coated balloon | Experimental | Device: Cutting balloon followed by paclitaxel coated balloon |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Recurrent stenoses (within 1 year after angioplasty) in the venous outflow of AVFs for dialysis access (> 0.5cm from AV anastomosis up to cephalic arch)
- Successful guidewire crossing of target lesion
- ≥ 21 years old
- Informed and valid consent given.
- Patient willing and able to return for follow up .
Key exclusion criteria (17 listed)
- Thrombosed AVFs or occlusions in the access circuit
- Significant cephalic arch (central perpendicular portion of the cephalic vein) or central vein stenoses.
- > 3 stenosed segments (lesions are considered separate if they are separated by at least 2 cm normal vessel.)
- Only potential target lesion located in cephalic arch, central veins or anastomotic lesions.
- Only de novo stenoses identifiable as target lesion.
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 followed by paclitaxel coated balloonCutting balloon followed by paclitaxel coated balloon | Device | Cutting balloon followed by paclitaxel coated balloon |
Primary outcome
Target lesion primary patency
Time frame: 1 year
Target lesion primary patency
2 secondary outcomes
Circuit primary patency
Time frame: 1 year
Target lesion primary assisted patency
Time frame: 1 year
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 24 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Dialysis Access Malfunction
Recruiting
Intravascular Ultrasound in Patients With End-stage Renal Disease on Dialysis
End Stage Renal Disease
Not yet recruitingObservational study
AVF Awareness Among Advanced CKD Patients
Chronic Kidney Diseases, Dialysis; Complications
RecruitingObservational study
Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
Chronic Kidney Diseases, End Stage Renal Disease on Dialysis
Not yet recruiting
Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients
End Stage Renal Failure, Hemodialysis, Vascular Access
Enrolling by invitation
Expanding and Promoting Alternative Care and kNowledge in Decision-making Trial
Chronic Kidney Disease
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 Phase 2 study testing Cutting balloon followed by paclitaxel coated balloon in people with Dialysis Access Malfunction, 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 5 inclusion and 17 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 24 Aug 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: 1 year). 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 24 Aug 2021.