Peripheral Arterial DiseaseNCT06029569
Rapamycin Coated Balloon Dilation Catheter for Arteriovenous Fistula
A study testing Rapamycin drug balloon angioplasty and Paclitaxel drug balloon angioplasty in people with Peripheral Arterial Disease, run by Shanghai Bomaian Medical Technology Co., Ltd.
Trial summary
Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Rapamycin drug balloon angioplasty and Paclitaxel drug balloon angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2023to 15 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AVF has been established, with mature development and at least one successful completion of hemodialysis；
- AVF has significant hemodynamic abnormalities；
Who cannot join
- The target lesion has undergone intervention treatment within 30 days；
- An intravascular stent has been placed at any location along the vascular pathway；
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Rapamycin Coated Balloon Dilation Catheter in the Treatment of Dialysis Pathway Stenosis or Blockage in Hemodialysis Patients
Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.
Read the detailed description
To verify the effectiveness and safety of the Rapamycin coated arteriovenous fistula balloon dilation catheter developed and produced by Shanghai Bomaian Medical Technology Co., Ltd. in the treatment of stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula in hemodialysis patients.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Rapamycin drug balloon angioplasty, Paclitaxel drug balloon angioplasty
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapamycin drug balloon angioplastyProcedure or surgery
Rapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula.
Paclitaxel drug balloon angioplastyProcedure or surgery
Paclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula.
| Study group | Role | What they receive |
|---|---|---|
| Rapamycin coated balloon dilation catheter for arteriovenous fistula | Experimental | Experimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion Receives: Procedure: Rapamycin drug balloon angioplasty; Procedure: Paclitaxel drug balloon angioplasty |
| Paclitaxel release high-pressure shunt balloon dilation catheter | Sham comparator | Strict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group Receives: Procedure: Rapamycin drug balloon angioplasty; Procedure: Paclitaxel drug balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month target lesion primary patency rate
Primary patency is defined as puncture dialysis that can be used to meet the requirements of the dialysis prescription without intervention treatment after the target lesion surgery.
Measured: 6months
Secondary outcomes (3)
Device success rate
The treatment device can be successfully transported, expanded, and withdrawn without any defects such as balloon rupture or loss of device integrity or design performance when expanded without exceeding the rated burst pressure.
Measured: The day of operation.
Surgical success rate
The residual stenosis of the target lesion is ≤ 30%, and there are no adverse events related to the target dialysis pathway related to medical devices within 7 days after surgery/before discharge.
Measured: 7Days
Clinical success rate
After the surgery, at least one puncture dialysis that meets the requirements of the dialysis prescription has been completed and no target pathway dysfunction has occurred before.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start15 Sep 2023 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Bomaian Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029569
- Sponsor's protocol ID
- BMA-AVF-DCB
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 8 Sep 2023
- 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 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Rapamycin Coated Balloon Dilation Catheter in the Treatment of Dialysis Pathway Stenosis or Blockage in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06029569
- Acronym / sponsor ID
- BMA-AVF-DCB
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Shanghai Bomaian Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 8 Sep 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.
Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.
Detailed description
To verify the effectiveness and safety of the Rapamycin coated arteriovenous fistula balloon dilation catheter developed and produced by Shanghai Bomaian Medical Technology Co., Ltd. in the treatment of stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula in hemodialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapamycin coated balloon dilation catheter for arteriovenous fistula | Experimental | Procedure: Rapamycin drug balloon angioplasty, Procedure: Paclitaxel drug balloon angioplastyExperimental group rapamycin balloon therapy for autologous arteriovenous fistulas with stenosis or occlusion |
| Paclitaxel release high-pressure shunt balloon dilation catheter | Sham comparator | Procedure: Rapamycin drug balloon angioplasty, Procedure: Paclitaxel drug balloon angioplastyStrict or occluded autologous arteriovenous fistula treated with paclitaxel balloon therapy in the control group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- AVF has been established, with mature development and at least one successful completion of hemodialysis；
- AVF has significant hemodynamic abnormalities；
Key exclusion criteria (2 listed)
- The target lesion has undergone intervention treatment within 30 days；
- An intravascular stent has been placed at any location along the vascular pathway；
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 |
|---|---|---|
| Rapamycin drug balloon angioplastyRapamycin drug balloon treatment for stenosis or blockage of the dialysis pathway in autologous arteriovenous fistula. | Procedure or surgery | Paclitaxel release high-pressure shunt balloon dilation catheter, Rapamycin coated balloon dilation catheter for arteriovenous fistula |
| Paclitaxel drug balloon angioplastyPaclitaxel drug balloon therapy for stenosis or blockage of the dialysis pathway of autologous arteriovenous fistula. | Procedure or surgery | Paclitaxel release high-pressure shunt balloon dilation catheter, Rapamycin coated balloon dilation catheter for arteriovenous fistula |
Primary outcome
6-month target lesion primary patency rate
Time frame: 6months
Primary patency is defined as puncture dialysis that can be used to meet the requirements of the dialysis prescription without intervention treatment after the target lesion surgery.
3 secondary outcomes
Device success rate
Time frame: The day of operation.
Surgical success rate
Time frame: 7Days
Clinical success rate
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Rapamycin drug balloon angioplasty and Paclitaxel drug balloon angioplasty in people with Peripheral Arterial Disease, run by Shanghai Bomaian Medical Technology 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 2 inclusion and 2 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 8 Sep 2023. 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. Some participants in this study may receive a placebo. 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 qizhuang Jin (010-83572211, jinqizhuang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month target lesion primary patency rate (time frame: 6months). 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 8 Sep 2023.