Arteriovenous FistulaAVFNCT05088083
Paclitaxel-Coated Balloon for the Treatment of AVF
A study testing Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon in people with Arteriovenous Fistula, run by Zhejiang Zylox Medical Device Co., Ltd..
Trial summary
To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arteriovenous Fistula
- What is being tested?
- Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Sep 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age during 18-85 years old
- Arteriovenous fistula is matured and has undergone one or more hemodialysis sessions
- Venous stenosis of the AV fistula
- target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1,the venous pressure increased significantly during dialysis. 2,abnormal physical examination. 3,Decrease in blood flow
- the length of target lesion ≤100mm
- Patient able to give informed consent
- residual stenosis ≤30% after predilation
Who cannot join
- Women who are breastfeeding, pregnant or are intending to become pregnant
- AVF located at lower limbs
- Two or more than two stenosis at the target vessel.
- Obstruction of central venous return
- ISR
- AVF with acute thrombosis requiring lysis or thrombectomy in 30 days
Show all 15Show fewer
- Vascular access has surgery in 30 days or intending to undergo a surgery
- Known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
- Patients undergoing immunotherapy or suspected / confirmed vasculitis
- Patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura
- Vascular access infection or systemic active infection
- Patients's life expectancy is less than 12 months
- Renal transplantation has been planned or converted to peritoneal dialysis
- Other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program
- Involved in other drugs, biology, medical device research, or has been involved in other similar products clinical Test
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Single-arm Study of Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)
To evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China.
- Conditions
- Arteriovenous Fistula
- Being tested
- Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
- Keywords
- DCB
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) BalloonDevice
Also called Zylox
After predilation, using drug-coated balloon catheter to cover the whole treated segment
| Study group | Role | What they receive |
|---|---|---|
| DCB Treatment Group | Experimental | Subjects treated with DCB Receives: Device: Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary patency of target lesion in 6 months
Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention; 2) PSVR< 2.4
Measured: 6 months
Secondary outcomes (3)
Device Success
Successful delivery to the target lesion, deployment, and retrieval at index procedure
Measured: Time of procedure
Clinical Success
The resumption of dialysis for at least one session after the index procedure
Measured: From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.
Procedural Success
Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study startDec 2021 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lan Zhang, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088083
- Sponsor's protocol ID
- V1.0
- Acronym
- AVF
- Status last verified
- Oct 2021
- First submitted
- 20 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm Study of Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF)
- ClinicalTrials.gov ID
- NCT05088083
- Acronym / sponsor ID
- AVF / V1.0
- Conditions
- Arteriovenous Fistula
- Keywords
- DCB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2021 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 21 Oct 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 evaluate the safety and efficacy of the Zylox Drug Coated Balloon (DCB) for treatment of subjects presenting with de novo or non-stented restenotic obstructive lesion of native arteriovenous dialysis fistulae (AVF) in the upper extremity in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCB Treatment Group | Experimental | Device: Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) BalloonSubjects treated with DCB |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age during 18-85 years old
- Arteriovenous fistula is matured and has undergone one or more hemodialysis sessions
- Venous stenosis of the AV fistula
- target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1,the venous pressure increased significantly during dialysis. 2,abnormal physical examination. 3,Decrease in blood flow
- the length of target lesion ≤100mm
Key exclusion criteria (15 listed)
- Women who are breastfeeding, pregnant or are intending to become pregnant
- AVF located at lower limbs
- Two or more than two stenosis at the target vessel.
- Obstruction of central venous return
- ISR
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 Percutaneous Transluminal Angioplasty (PTA) BalloonAlso: ZyloxAfter predilation, using drug-coated balloon catheter to cover the whole treated segment | Device | DCB Treatment Group |
Primary outcome
primary patency of target lesion in 6 months
Time frame: 6 months
Primary Patency is defined as the freedom of reintervention for the target lesion,including: 1)clinical driven target lesion reintervention; 2) PSVR< 2.4
3 secondary outcomes
Device Success
Time frame: Time of procedure
Clinical Success
Time frame: From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.
Procedural Success
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Arteriovenous Fistula
Enrolling by invitationObservational study
Okami Medical ALPHA Registry
Arterial Bleed, Pulmonary Arteriovenous Malformation
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
Not yet recruiting
DialysisBot: AI Chatbot for Hemodialysis Self-Management
Chatbot-Based Training, Hemodialysis
RecruitingObservational study
NAIF 2.0 - COGNIFY
Dural Arteriovenous Fistula, Glymphatic System
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.
Lan Zhang principal investigator
RenJi Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon in people with Arteriovenous Fistula, run by Zhejiang Zylox Medical Device Co., Ltd..
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 7 inclusion and 15 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 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Jie Liang, Bachelor (13819565660, jie.liang@zyloxmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary patency of target lesion in 6 months (time frame: 6 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 21 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.