Hemodialysis Access Failure (Disorder)NCT03360279
DCB for Dialysis Access Stent Graft Restenosis
A study testing Regular balloon and DCB (paclitaxel-coated balloon) in people with Hemodialysis Access Failure (Disorder) and Stent-Graft Restenosis, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
Trial summary
Recurrent stenosis in hemodialysis access graft (AVG) is difficult to treat. For recurrent stenosis in the anastomotic junction can be treated by stent graft to improve long-term patency. However, there is no data regarding treatment of stent graft restenosis in AVG. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Hemodialysis Access Failure (Disorder), Stent-Graft Restenosis, Arteriovenous Graft
- What is being tested?
- Regular balloon and DCB (paclitaxel-coated balloon)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Mar 2017to 31 Dec 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 20 to 90 years on regular hemodialysis at least 3 months
- Had stent graft implemented at dialysis vascular access
- Angiographic evidence of stenosis within the stent graft or less than 2 cm from the stent graft edge
- Clinical evidence of a hemodynamically significant stenosis or thrombosis
- Patient is able to provide written informed consent
Who cannot join
- Elbow fracture or any disease involve the elbow joint that prohibits the flexion maneuver.
- Target lesion cannot be crossed by the guide wire.
- Known hypersensitivity to heparin or contrast medium.
- Bleeding diathesis.
- Patients participating in another clinical trial with interfering with this trial in the past three months.
- Untreatable bleeding diathesis.
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- Other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patient's life expectancy (less than 3 months).
- Patients unable or unwilling to participate this trial.
- Pregnancy, lactating woman, non-adult, criminals in sentence, psychiatric patients, research staffs or colleagues are prohibited.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Hsinchu Branch
Hsinchu, Hsinchu City, 300
Chiu-Kuei Nien, RN, 886-35326151 ext. 8853, hch01215@hch.gov.tw
Jen-Jin Chen, RN, 886-35326151 ext. 8665, cychen1@hch.gov.tw
About this study
Official title: A Randomized Trial Comparing Drug-coated Balloon and Regular Balloon for Dialysis Access Stent Graft Restenosis
Recurrent stenosis in hemodialysis access graft (AVG) is difficult to treat. For recurrent stenosis in the anastomotic junction can be treated by stent graft to improve long-term patency. However, there is no data regarding treatment of stent graft restenosis in AVG. This randomized trial is designed to compare the efficacy and safety of drug-coated balloon (DCB) versus regular balloon in AVG stent graft restenosis.
Read the detailed description
Prosthetic arteriovenous hemodialysis access graft (AVG) has high incidences of venous anastomotic stenosis and access failure. A stent graft can be used in AVG with recurrent venous anastomotic stenosis to improve long-term patency rate. However, after stent graft implementation, the effective treatment for restenosis in a stent graft is still unknown. This randomized trial is designed to evaluate the efficacy and safety of drug-coated balloon versus regular balloon for in-stent restenosis in stent graft. The investigators plan to enroll 40 patients who presented with prosthetic AVG in-stent restenosis, and then to evaluate the restenosis lesions by intravascular ultrasound. Patients will be randomized into two groups of treatment: drug-coated balloon angioplasty or regular balloon angioplasty.
- Conditions
- Hemodialysis Access Failure (Disorder), Stent-Graft Restenosis, Arteriovenous Graft, Drug-coated Balloon
- Being tested
- Regular balloon, DCB (paclitaxel-coated balloon)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular balloonDevice
Randomization: to use regular balloon to treat stent graft restenosis
DCB (paclitaxel-coated balloon)Device
Randomization: to use DCB (paclitaxel-coated balloon, Ranger, Boston-Scientific) to treat stent graft restenosis. The paclitaxel dose is 2 ug/mm2 delivered with the Ranger drug-coated balloon.
| Study group | Role | What they receive |
|---|---|---|
| Regular balloon | Active comparator | Use the regular balloon to perform standard balloon angioplasty. Receives: Device: Regular balloon |
| DCB (paclitaxel-coated balloon) | Active comparator | Use DCB (paclitaxel-coated balloon) to perform additional balloon angioplasty. Receives: Device: DCB (paclitaxel-coated balloon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late luminal loss
The late luminal loss found by IVUS on follow-up in comparison to index procedure.
Measured: 0, 1, and 3 months
Secondary outcomes (4)
minimal luminal area and diameter
Done by IVUS on follow-up in comparison to index procedure.
Measured: 0, 1, and 3 months
restenosis rate
Compare with follow-up angiography.
Measured: 0, 1, and 3 months
repeated intervention
defined by repeated endovascular balloon angioplasty or endovascular thrombectomy or surgical open thrombectomy.
Measured: 0, 1, and 3 months
abandon of AV graft, death
stopped to use the target AVG or mortality
Measured: 0, 1, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start5 Mar 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis Access Failure (Disorder)Studies 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
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch
- Investigators
- Mu-Yang Hsieh, MD, Principal investigator, National Taiwan University Hospital Hsin-Chu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360279
- Sponsor's protocol ID
- 105-015-F
- Status last verified
- Nov 2017
- First submitted
- 12 Nov 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang H, Qin J, Liu C, Gao X, Ma L, Cui S, Lu X, Lu S, Huang Z, Tong Z, Guo L, Guo J. Cold Laser vs Excimer Laser in Lower Limb Atherosclerosis: A Prospective Multicenter Randomized Trial. JACC Cardiovasc Interv. 2026 Apr 27;19(8):1021-1035. doi: 10.1016/j.jcin.2026.02.036.
PubMed 42055649Hsieh MY, Lin PS, Liao MT, Lin L, Chen TY, Boon JC, Yang TF, Wu CC. A Randomised Trial Comparing Drug Coated Balloons and Conventional Balloons for the Treatment of Stent Graft Stenosis in Dialysis Vascular Access. Eur J Vasc Endovasc Surg. 2023 Aug;66(2):253-260. doi: 10.1016/j.ejvs.2023.05.028. Epub 2023 May 18.
PubMed 37209996
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Drug-coated Balloon and Regular Balloon for Dialysis Access Stent Graft Restenosis
- ClinicalTrials.gov ID
- NCT03360279
- Acronym / sponsor ID
- 105-015-F
- Conditions
- Hemodialysis Access Failure (Disorder), Stent-Graft Restenosis, Arteriovenous Graft, Drug-coated Balloon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 5 Mar 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 4 Dec 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.
Recurrent stenosis in hemodialysis access graft (AVG) is difficult to treat. For recurrent stenosis in the anastomotic junction can be treated by stent graft to improve long-term patency. However, there is no data regarding treatment of stent graft restenosis in AVG. This randomized trial is designed to compare the efficacy and safety of drug-coated balloon (DCB) versus regular balloon in AVG stent graft restenosis.
Detailed description
Prosthetic arteriovenous hemodialysis access graft (AVG) has high incidences of venous anastomotic stenosis and access failure. A stent graft can be used in AVG with recurrent venous anastomotic stenosis to improve long-term patency rate. However, after stent graft implementation, the effective treatment for restenosis in a stent graft is still unknown. This randomized trial is designed to evaluate the efficacy and safety of drug-coated balloon versus regular balloon for in-stent restenosis in stent graft. The investigators plan to enroll 40 patients who presented with prosthetic AVG in-stent restenosis, and then to evaluate the restenosis lesions by intravascular ultrasound. Patients will be randomized into two groups of treatment: drug-coated balloon angioplasty or regular balloon angioplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular balloon | Active comparator | Device: Regular balloonUse the regular balloon to perform standard balloon angioplasty. |
| DCB (paclitaxel-coated balloon) | Active comparator | Device: DCB (paclitaxel-coated balloon)Use DCB (paclitaxel-coated balloon) to perform additional balloon angioplasty. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 20 to 90 years on regular hemodialysis at least 3 months
- Had stent graft implemented at dialysis vascular access
- Angiographic evidence of stenosis within the stent graft or less than 2 cm from the stent graft edge
- Clinical evidence of a hemodynamically significant stenosis or thrombosis
- Patient is able to provide written informed consent
Key exclusion criteria (9 listed)
- Elbow fracture or any disease involve the elbow joint that prohibits the flexion maneuver.
- Target lesion cannot be crossed by the guide wire.
- Known hypersensitivity to heparin or contrast medium.
- Bleeding diathesis.
- Patients participating in another clinical trial with interfering with this trial in the past three months.
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 |
|---|---|---|
| Regular balloonRandomization: to use regular balloon to treat stent graft restenosis | Device | Regular balloon |
| DCB (paclitaxel-coated balloon)Randomization: to use DCB (paclitaxel-coated balloon, Ranger, Boston-Scientific) to treat stent graft restenosis. The paclitaxel dose is 2 ug/mm2 delivered with the Ranger drug-coated balloon. | Device | DCB (paclitaxel-coated balloon) |
Primary outcome
Late luminal loss
Time frame: 0, 1, and 3 months
The late luminal loss found by IVUS on follow-up in comparison to index procedure.
4 secondary outcomes
minimal luminal area and diameter
Time frame: 0, 1, and 3 months
restenosis rate
Time frame: 0, 1, and 3 months
repeated intervention
Time frame: 0, 1, and 3 months
abandon of AV graft, death
Time frame: 0, 1, and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Derived from this study: PubMed 42055649Wang H, Qin J, Liu C, Gao X, Ma L, Cui S, Lu X, Lu S, Huang Z, Tong Z, Guo L, Guo J. Cold Laser vs Excimer Laser in Lower Limb Atherosclerosis: A Prospective Multicenter Randomized Trial. JACC Cardiovasc Interv. 2026 Apr 27;19(8):1021-1035. doi: 10.1016/j.jcin.2026.02.036.
- Derived from this study: PubMed 37209996Hsieh MY, Lin PS, Liao MT, Lin L, Chen TY, Boon JC, Yang TF, Wu CC. A Randomised Trial Comparing Drug Coated Balloons and Conventional Balloons for the Treatment of Stent Graft Stenosis in Dialysis Vascular Access. Eur J Vasc Endovasc Surg. 2023 Aug;66(2):253-260. doi: 10.1016/j.ejvs.2023.05.028. Epub 2023 May 18.
- Individual participant dataSharing planned: Undecided
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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.
Mu-Yang Hsieh, MD principal investigator
National Taiwan University Hospital Hsin-Chu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular balloon and DCB (paclitaxel-coated balloon) in people with Hemodialysis Access Failure (Disorder) and Stent-Graft Restenosis, 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 5 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: status not confirmed, as of the sponsor's last update on 4 Dec 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mu-Yang Hsieh, MD (886-35326151 ext. 2009, h11135@hch.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late luminal loss (time frame: 0, 1, and 3 months). 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 NCT03360279, which also lists 2 linked publications.
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 4 Dec 2017.