Kidney Failure, ChronicNCT03388892
Drug-Eluting Balloon in Arteriovenous Graft
A study testing paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy) and Plain Balloon in people with Kidney Failure, Chronic and Angioplasty, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
Trial summary
The investigators' study aims is to evaluate the safety and efficacy of percutaneous transluminal angioplasty (PTA) with paclitaxel-coated balloon (PCB) at venous anastomotic stenosis of arteriovenous graft (AVG) in patients with hemodialysis Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Failure, Chronic, Angioplasty, Dialysis
- What is being tested?
- paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy) and Plain Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Jan 2015to 20 Nov 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 90 years
- Patients under hemodialysis via prosthetic arteriovenous graft in the arm
- Vascular access was created for more than 30 days and used at least one successful session
- Clinical failure for hemodialysis due to higher venous pressure or lower arterial flow
- Angiography proved venous anastomotic stenosis ≥50% (the entire lesion of venous anastomotic stenosis will be extended into AVG no more than 2cm and naive vein no more than 7 cm). There was no other obvious stenosis.
- Reference diameter of venous anastomosis within 7 mm
Who cannot join
- Patient could not write informed consent
- Being unwilling or unable to return for follow-up visits or reason to believe that adherence to follow-up visits would be irregular
- Current or scheduled enrollment in other, conflicting studies.
- Acute thrombosis in the past 3 months
- Central venous stenosis
- Concomitant disease (e.g., terminal cancer) or other medical condition likely to result in death within 6 months
Show all 10Show fewer
- A blood coagulation disorder
- Sepsis or infected arteriovenous access graft
- A contraindication to the use of contrast medium
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Drug-Eluting Balloon Angioplasty in Venous Anastomotic Stenosis of Dialysis Arteriovenous Graft
The investigators' study aims is to evaluate the safety and efficacy of percutaneous transluminal angioplasty (PTA) with paclitaxel-coated balloon (PCB) at venous anastomotic stenosis of arteriovenous graft (AVG) in patients with hemodialysis
- Conditions
- Kidney Failure, Chronic, Angioplasty, Dialysis
- Being tested
- paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy), Plain Balloon
- Keywords
- Angioplasty, Drug Eluting Balloon, Arteriovenous Graft
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy)Device
Arteriovenous graft (AVG) dysfunction or acute thrombosis is mainly caused by neointimal hyperplasia. Although endovascular intervention, such as percutaneous transluminal angioplasty (PTA), catheter-based directed thrombolysis with urokinase, mechanical thrombectomy with percutaneous thrombolytic device or even if graft stenting, can salvage the hemodialysis access, the long-term primary and secondary patent rate don't improve due to repeated restenosis from neointimal hyperplasia. Drug eluting balloon is used in reducing neointimal hypoplasia in patients with coronary in-stent restenosis and it's also effective in restenosis of peripheral arterial diseases. It's reasonable to hypothesize that PTA with PCB at venous anastomotic stenosis of AVG could prolong the patency and reduce the acute thrombosis rate.
Plain BalloonDevice
Traditional Plain Balloon was used to dilate the venous anastomotic stenosis of arteriovenous graft (AVG) as the usual intervention
| Study group | Role | What they receive |
|---|---|---|
| Drug-Eluting Balloon | Experimental | PTA with DEB at venous anastomotic stenosis of AVG Receives: Device: paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy) |
| Plain Balloon | Active comparator | PTA with PCB at venous anastomotic stenosis of AVG Receives: Device: Plain Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
patent rate in percentage after PTA
Late luminal loss in patients was evaluated by quantitative angiography after PTA and intravascular ultrasound (IVUS) up to 12 months after PTA. Late luminal loss is defined as the difference between the minimal lumen diameter in percentage and the late luminal loss less than 50% was defined as patency.
Measured: 1 year
Secondary outcomes (6)
The incidence of angiography-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)
Measure the stenotic percentage every 2 months up to 1 year for angiography
Measured: 1 year
The incidence of IVUS-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)
Measure the stenotic percentage 1, 6, 12 months for IVUS
Measured: 1 year
Change of AVG flow in liter per minute
measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA
Measured: 1 year
Change of AVG pressure in mmHg
measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA
Measured: 1 year
Time interval of patent AVG after PTA
Patent AVG was defined as luminal loss less than 50%
Measured: 1 year
The rate of AVG failure at 6 months and 12 months
AVG failure was defined as AVG thrombosis, AVG re-intervention
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 posted3 Jan 2018
- Study start29 Jan 2015
- Primary completion25 Jul 2017
- Study completion20 Nov 2018
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 Kidney Failure, ChronicStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388892
- Sponsor's protocol ID
- 103-065-F
- Status last verified
- Nov 2018
- First submitted
- 2 Dec 2015
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liao MT, Lee CP, Lin TT, Jong CB, Chen TY, Lin L, Hsieh MY, Lin MS, Chie WC, Wu CC. A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts. J Vasc Surg. 2020 Jun;71(6):1994-2003. doi: 10.1016/j.jvs.2019.07.090. Epub 2019 Oct 11.
PubMed 31611105
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Drug-Eluting Balloon Angioplasty in Venous Anastomotic Stenosis of Dialysis Arteriovenous Graft
- ClinicalTrials.gov ID
- NCT03388892
- Acronym / sponsor ID
- 103-065-F
- Conditions
- Kidney Failure, Chronic, Angioplasty, Dialysis
- Keywords
- Angioplasty, Drug Eluting Balloon, Arteriovenous Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 29 Jan 2015 (actual)
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 3 Jan 2018 (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.
The investigators' study aims is to evaluate the safety and efficacy of percutaneous transluminal angioplasty (PTA) with paclitaxel-coated balloon (PCB) at venous anastomotic stenosis of arteriovenous graft (AVG) in patients with hemodialysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-Eluting Balloon | Experimental | Device: paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy)PTA with DEB at venous anastomotic stenosis of AVG |
| Plain Balloon | Active comparator | Device: Plain BalloonPTA with PCB at venous anastomotic stenosis of AVG |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 90 years
- Patients under hemodialysis via prosthetic arteriovenous graft in the arm
- Vascular access was created for more than 30 days and used at least one successful session
- Clinical failure for hemodialysis due to higher venous pressure or lower arterial flow
- Angiography proved venous anastomotic stenosis ≥50% (the entire lesion of venous anastomotic stenosis will be extended into AVG no more than 2cm and naive vein no more than 7 cm). There was no other obvious stenosis.
Key exclusion criteria (10 listed)
- Patient could not write informed consent
- Being unwilling or unable to return for follow-up visits or reason to believe that adherence to follow-up visits would be irregular
- Current or scheduled enrollment in other, conflicting studies.
- Acute thrombosis in the past 3 months
- Central venous stenosis
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 |
|---|---|---|
| paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy)Arteriovenous graft (AVG) dysfunction or acute thrombosis is mainly caused by neointimal hyperplasia. Although endovascular intervention, such as percutaneous transluminal angioplasty (PTA), catheter-based directed thrombolysis with urokinase, mechanical thrombectomy with percutaneous thrombolytic device or even if graft stenting, can salvage the hemodialysis access, the long-term primary and secondary patent rate don't improve due to repeated restenosis from neointimal hyperplasia. Drug eluting balloon is used in reducing neointimal hypoplasia in patients with coronary in-stent restenosis and it's also effective in restenosis of peripheral arterial diseases. It's reasonable to hypothesize that PTA with PCB at venous anastomotic stenosis of AVG could prolong the patency and reduce the acute thrombosis rate. | Device | Drug-Eluting Balloon |
| Plain BalloonTraditional Plain Balloon was used to dilate the venous anastomotic stenosis of arteriovenous graft (AVG) as the usual intervention | Device | Plain Balloon |
Primary outcome
patent rate in percentage after PTA
Time frame: 1 year
Late luminal loss in patients was evaluated by quantitative angiography after PTA and intravascular ultrasound (IVUS) up to 12 months after PTA. Late luminal loss is defined as the difference between the minimal lumen diameter in percentage and the late luminal loss less than 50% was defined as patency.
6 secondary outcomes
The incidence of angiography-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)
Time frame: 1 year
The incidence of IVUS-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)
Time frame: 1 year
Change of AVG flow in liter per minute
Time frame: 1 year
Change of AVG pressure in mmHg
Time frame: 1 year
Time interval of patent AVG after PTA
Time frame: 1 year
The rate of AVG failure at 6 months and 12 months
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 23 Nov 2018.
- Derived from this study: PubMed 31611105Liao MT, Lee CP, Lin TT, Jong CB, Chen TY, Lin L, Hsieh MY, Lin MS, Chie WC, Wu CC. A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts. J Vasc Surg. 2020 Jun;71(6):1994-2003. doi: 10.1016/j.jvs.2019.07.090. Epub 2019 Oct 11.
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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 paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy) and Plain Balloon in people with Kidney Failure, Chronic and Angioplasty, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
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 6 inclusion and 10 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 23 Nov 2018. 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 Taiwan. 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?
patent rate in percentage after PTA (time frame: 1 year). 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 NCT03388892, 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 23 Nov 2018.