Stenosis of Native Hemodialysis Arteriovenous FistulasNCT06205576
ACOART AVF RENEW: A Post Market Clinical Study
A study testing DCB catheter in people with Stenosis of Native Hemodialysis Arteriovenous Fistulas, run by Acotec Scientific Co., Ltd at 1 site in China.
Trial summary
The objective of this prospective，multi-center，single arm study is to obtain further data on the safety and performance of the Acotec Orchid＆Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in the native Arteriovenous Dialysis Fistulae (AVF). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stenosis of Native Hemodialysis Arteriovenous Fistulas
- What is being tested?
- DCB catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient is ≥18 and ≤85 years of age
- The target AV fistula has undergone successful dialysis for at least 1 time
- Patient has a de novo and/or non-stented restenotic lesion located in the outflow vein（Arteries and Central Vein are excluded）
- Patient has a de novo and/or non-stented restenotic lesion（≥50% stenosis）and at least one of the following occurs：
- The physical examination was abnormal
- Significant increase in dynamic venous pressure
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- Blood flow decreased significantly
- Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length
- Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a PTA balloon defined as:
- Residual stenosis of ≤ 30% AND
- Absence of a flow limiting dissection (Grade ≥C) or perforation
- Patient provides written informed consent prior to enrollment in the study
Who cannot join
- Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
- Dialysis access is located in the lower extremity
- More than one lesion
- Patient with hemodynamically significant central venous stenoses
- Patient has presence of a stent located in the target AV access circuit
- Patient has undergone prior intervention of access site within 30 days of index procedure
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- Patient with target AVF or access circuit which previously had or currently has a plan to surgery
- Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy
- Patients undergoing immunotherapy or suspected/confirmed vasculitis
- Patients with a history of coagulation dysfunction, thrombocytopenic purpura or RH-negative blood type
- Patient has an infected AV access or systemic infection
- Patient has a life expectancy of <24 months
- Patient is anticipating a kidney transplant or with anticipated conversion to peritoneal dialysis
- Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation
- Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint, or was previously enrolled in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Haidian Hospital
Beijing
Zhang Li Hong
About this study
Official title: A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon for the Treatment of the Obstructive Lesions in the Native Arteriovenous Dialysis Fistuae(AVF)
The objective of this prospective，multi-center，single arm study is to obtain further data on the safety and performance of the Acotec Orchid＆Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in the native Arteriovenous Dialysis Fistulae (AVF).
- Being tested
- DCB catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCB catheterDevice
Trade name of DCB catheter：Acoart Orchid＆Dhalia
| Study group | Role | What they receive |
|---|---|---|
| DCB catheter | Experimental | Using DCB catheter for the treatment of subjects with a de novo or non-stented restenotic obstructive lesion located in the native arteriovenous dialysis fistulae. Receives: Device: DCB catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Primary Patency Rate
Defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured.
Measured: 6 months
Serious Adverse Event Rate
Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit.
Measured: 30 days
Secondary outcomes (2)
Target Lesion Primary Patency Rate
Defined as freedom from CD-TLR or access thrombosis occurring in the target lesion post-procedure.
Measured: 12 months，24 months
All-cause mortality Rate
All-cause mortality post procedure
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start20 Feb 2023
- Primary completionDec 2025 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosis of Native Hemodialysis Arteriovenous FistulasStudies 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
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acotec Scientific Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205576
- Sponsor's protocol ID
- ACOART AVF RENEW
- Status last verified
- Jan 2024
- First submitted
- 4 Jan 2024
- Last updated
- 16 Jan 2024
- 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 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon for the Treatment of the Obstructive Lesions in the Native Arteriovenous Dialysis Fistuae(AVF)
- ClinicalTrials.gov ID
- NCT06205576
- Acronym / sponsor ID
- ACOART AVF RENEW
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Acotec Scientific Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Jan 2024 (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 objective of this prospective，multi-center，single arm study is to obtain further data on the safety and performance of the Acotec Orchid＆Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in the native Arteriovenous Dialysis Fistulae (AVF).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCB catheter | Experimental | Device: DCB catheterUsing DCB catheter for the treatment of subjects with a de novo or non-stented restenotic obstructive lesion located in the native arteriovenous dialysis fistulae. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient is ≥18 and ≤85 years of age
- The target AV fistula has undergone successful dialysis for at least 1 time
- Patient has a de novo and/or non-stented restenotic lesion located in the outflow vein（Arteries and Central Vein are excluded）
- Patient has a de novo and/or non-stented restenotic lesion（≥50% stenosis）and at least one of the following occurs：
- Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length
Key exclusion criteria (15 listed)
- Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
- Dialysis access is located in the lower extremity
- More than one lesion
- Patient with hemodynamically significant central venous stenoses
- Patient has presence of a stent located in the target AV access circuit
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 |
|---|---|---|
| DCB catheterTrade name of DCB catheter：Acoart Orchid＆Dhalia | Device | DCB catheter |
Primary outcome
Target Lesion Primary Patency Rate
Time frame: 6 months
Defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured.
Serious Adverse Event Rate
Time frame: 30 days
Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit.
2 secondary outcomes
Target Lesion Primary Patency Rate
Time frame: 12 months，24 months
All-cause mortality Rate
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCB catheter in people with Stenosis of Native Hemodialysis Arteriovenous Fistulas, run by Acotec Scientific Co., Ltd at 1 site in China.
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 12 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: looking for participants now, as of the sponsor's last update on 16 Jan 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Yu Zhu (010-82693657, wangyuzhu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Primary Patency Rate (time frame: 6 months). The study lists 2 primary outcomes in all. 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 16 Jan 2024.